CELERITY HP Chemical Indicator

K213262 · STERIS Corporation · QKM · Jan 7, 2022 · General Hospital

Device Facts

• Record ID: K213262
• Device Name: CELERITY HP Chemical Indicator
• Applicant: STERIS Corporation
• Product Code: QKM · General Hospital
• Decision Date: Jan 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Celerity™ HP 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 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.

Device Story

Celerity HP Chemical Indicator is a multivariable chemical indicator strip for monitoring vaporized hydrogen peroxide (VHP) sterilization cycles. Device consists of reactive indicator ink printed on a polypropylene strip. When exposed to VHP sterilization cycles, ink changes color from magenta to orange/yellow or lighter yellow if critical variables (time, temperature, sterilant concentration) are achieved. Used in clinical settings to verify sterilization cycle efficacy. Healthcare providers visually inspect the indicator post-cycle; color change confirms cycle completion. Provides quality assurance for sterilized instruments, ensuring patient safety by confirming sterilization parameters were met.

Clinical Evidence

Bench testing only. Performance verified against ANSI/AAMI/ISO 11140-1:2014 requirements for Type 4 VHP chemical indicators. Testing confirmed reaction to critical variables (time, temperature, concentration) and endpoint color stability up to 15 months. Simulated use testing (leveraged from K192020) confirmed performance in commercial sterilizers with worst-case loads, showing complete color change in full cycles and incomplete change in abbreviated cycles.

Technological Characteristics

Chemical indicator strip; polypropylene substrate; proprietary VHP-reactive ink. Multivariable indicator (Type 4 per ISO 11140-1:2014). Dimensions/form factor: strip. No energy source or software. Sterilization monitoring principle: chemical reaction to VHP exposure (4.7 mg/L, 29 seconds, 50°C).

Indications for Use

Indicated for routine monitoring of vaporized hydrogen peroxide sterilization cycles in V-PRO® Low Temperature Sterilization Systems and ASP STERRAD® Systems (including those with ALLClear Technology).

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

• 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (K203284)

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 seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

January 7, 2022

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

Re: K213262

Trade/Device Name: CELERITY HP Chemical Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: QKM Dated: December 7, 2021 Received: December 8, 2021

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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

542 of the Act); 21 CFR 1000-1050.

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-

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,

Clarence W. Murray, III, PhD 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

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

## Indications for Use

510(k) Number (if known) K213262

Device Name Celerity™ HP Chemical Indicator

### Indications for Use (Describe)

The Celerity™ HP 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 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.

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 PRAStaff(@fda.hhs.gov

"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}------------------------------------------------

# STI

# 510(k) Summary For 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] |

| Submission Date: | January 6, 2022 |
|------------------|-----------------|
|------------------|-----------------|

K213262 510K number:

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

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

## STERIS Traditional 510(k) PREMARKET NOTIFICATION K213262 CELERITY HP Chemical Indicator (CI)

#### 1. Predicate Device

| Trade Name: | 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric<br>Chemical Indicator 1348/1348E |
|--------------------------|-------------------------------------------------------------------------------------|
| Common/Usual Name: | Chemical Indicator Classification: |
| | Class II |
| Classification Name: | Physical/chemical sterilization processindicator |
| 510(k) Submitter/Holder: | 3M Corporation |
| 510(k) Number: | K203284 |

#### 2. Device Description

The Celerity™ HP 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 multivariable indicator claims.

#### 3. Indications for Use

The Celerity™ HP 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 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 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 similar and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible color change.

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

## STERIS Traditional 510(k) PREMARKET NOTIFICATION K213262 CELERITY HP Chemical Indicator (CI)

| Feature | Proposed: Celerity™ HP | Predicate: K203284, 3M Attest | Comparison |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Chemical Indicator | Tri-Metric Chemical Indicator | |
| Intended Use /<br>Indications for<br>Use | The Celerity™ HP Chemical<br>Indicator is a vaporized hydrogen<br>peroxide multivariable chemical<br>indicator. It is designed for<br>routine monitoring of the<br>following cycles:<br>• Lumen, Non Lumen,<br>Flexible, Fast Non Lumen or<br>Fast sterilization cycle of a V-<br>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. | Use the 3MTM Attest™ Vaporized<br>Hydrogen Peroxide Tri-Metric Chemical<br>Indicator 1348/1348E for pack control<br>monitoring of the following hydrogen<br>peroxide sterilization sterilizers and<br>cycles: STERRAD® 100S System,<br>STERRAD® NX® System (Standard and<br>Advanced cycles), STERRAD® NX®<br>System with AllClear™ Technology<br>(Standard and Advanced cycles),<br>STERRAD® 100NX® System (Standard,<br>Flex, Express and Duo cycles)<br>STERRAD® 100NX® System with<br>AllClear™ Technology (Standard, Flex,<br>Express and Duo cycles) vaporized<br>hydrogen peroxide sterilizers and<br>STERIS® V-PRO® 1 (Lumen cycle),<br>STERIS® V-PRO® 1 Plus (Lumen and<br>Non-Lumen cycles) and STERIS® V-<br>PRO® maX Low Temperature<br>Sterilization System (Lumen, Non-<br>Lumen and Flexible cycles), STERIS®<br>V-PRO® 60 Temperature Sterilization<br>System (Lumen, Non-Lumen and<br>Flexible cycles), STERIS® V-PRO®<br>maX 2 Temperature Sterilization System<br>(Lumen, Non-Lumen, Flexible, and Fast<br>Non-lumen cycles), STERIS® V- PRO®<br>s2 Low Temperature Sterilization<br>System (Lumen, Non- Lumen, Flexible,<br>and Fast cycles) | Both predicate and subject<br>indicators are used for<br>monitoring the same<br>STERRAD and V-PRO<br>sterilization cycles. |
| Device design | Indicator Ink printed<br>onto polypropylene. | The 3MTM Attest™ Vaporized<br>Hydrogen Peroxide Tri-Metric<br>Chemical Indicator 1348/1348E is a<br>chemical indicator consisting of a non-<br>cellulose based coated indicator strip<br>sensitive to vaporized hydrogen<br>peroxide, contained in a film laminate | Both proposed and predicate<br>devices have a VH2O2<br>reactive ink on a non-<br>cellulosic substrate that<br>demonstrates a color change<br>when exposed to VH2O2. |
| Indicator agent | Proprietary | Proprietary | Both proposed and<br>predicate devices have a<br>VH2O2 reactive ink that<br>demonstrates a color<br>change when exposed to<br>VH2O2. |
| Critical<br>parameters | 4.7 mg/L - VH2O2<br>29 second - exposure time<br>50 °C - exposure Temperature | 5.1 mg/L - VH2O2<br>1 minute - exposure time<br>50 °C - exposure Temperature | Both proposed and<br>predicate devices only<br>react when all the variables<br>are reached. |
| Color change | Magenta to orange/yellow or<br>lighter yellow | Blue to pink with a moving dye front | Both proposed and<br>predicate devices use color<br>changes that are the same<br>as other cleared devices. |
| Endpoint<br>stability | 15 months | At least one month (4 weeks) | Both proposed and predicate<br>devices include labeling to<br>indicate endpoint stability. |

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

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

## STERIS Traditional 510(k) PREMARKET NOTIFICATION K213262 CELERITY HP Chemical Indicator (CI)

The predicate and proposed devices are similar in terms of basic scientific technology and indications for use. Testing is included in the submission to demonstrate that the proposed CI meets the criteria of a multivariable indicator and to extend the endpoint color stability. The multivariable indicator claims change the product code from JOJ to QKM. Both product codes are under regulation number 21 CFR 880.2800.

#### .. Performance Testing

Performance testing was conducted to verify that the proposed Celerity CI meets the requirements for multivariable chemical indicator using the Type 4 vaporized hydrogen peroxide sterilization indicator requirements defined in ANSI/AAMI/ISO 11140-1:2014. In addition, ongoing endpoint color stability testing has demonstrated stability throughout 15 months, so the labeling has been updated to reflect this.

| Testing | Purpose | Acceptance Criteria | Study Result |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Multivariable CI<br>Performance<br>Testing | Demonstrates that the indicator<br>reacts to all critical variables | Pass testing per Table 8<br>of ISO 11140-1:2014 | Pass. All CI show a<br>complete color change |
| | (time, temperature and sterilant<br>concentration) of the<br>sterilization process. | Fail testing per Table 8<br>of ISO 11140-1:2014 | Pass. All CI show an<br>incomplete color change |
| Endpoint color<br>stability | Demonstrates that the<br>processed indicator color does<br>not significantly change over<br>the labeled time period. | Color remains stable | Pass. Color stable up to<br>15 months |
| Simulated Use<br>Testing<br>(Leveraged from<br>K192020) | Demonstrates that the indicator<br>performs as expected in a<br>commercial sterilizer with<br>worst-case load. | Complete color change in<br>a full cycle.<br>Incomplete color change<br>in an abbreviated cycle. | Pass.<br>Complete color change in<br>a full cycle.<br>Incomplete color change<br>in an abbreviated cycle. |

Table 5-1. Verification Results Summary

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

#### 6. Conclusion

The conclusion drawn from the non-clinical test demonstrate that the subject device is as safe, as effective and perform as well as or better that the legally marketed predicate device (K203284, Class II as per 21 CFR 880.2800, product code QKM).