Celerity 20 Steam Biological Indicator for IUSS

K202721 · STERIS Corporation · FRC · Jan 8, 2021 · General Hospital

Device Facts

• Record ID: K202721
• Device Name: Celerity 20 Steam Biological Indicator for IUSS
• Applicant: STERIS Corporation
• Product Code: FRC · General Hospital
• Decision Date: Jan 8, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Celerity 20 STEAM Biological Indicator for IUSS is used for monitoring and qualification testing of the following steam sterilization cycles: Gravity 270°F (132°C) 3 minutes Gravity 270°F (132°C) 10 minutes Gravity 275°F (135°C) 3 minutes Gravity 275°F (135°C) 10 minutes. When used in conjunction with the Celerity STEAM Incubator provides a fluorescent result within 20 minutes.

Device Story

Biological indicator for monitoring steam sterilization cycles; contains Geobacillus stearothermophilus spores and nutrient media with fluorogenic substrate. Device placed in sterilizer; after cycle, placed in Celerity STEAM Incubator. Incubator detects fluorescent signal produced by reporter enzyme activity if spores survive. Provides result in 20 minutes. Used by healthcare personnel to confirm sterilization efficacy; negative result indicates successful sterilization; positive result indicates potential failure. Enables rapid verification of sterilization process, ensuring patient safety by confirming instrument sterility before use.

Clinical Evidence

Bench testing only. Performance validated via RIT testing (>97% alignment with 7-day conventional incubation), spore population counts (1.0-4.0 x 10^6), resistance testing (D132 ≥ 10s, D135 ≥ 8s), survival time, carrier growth inhibition, hold time, and simulated use testing. All tests passed.

Technological Characteristics

Biological indicator containing Geobacillus stearothermophilus spores (1.0-4.0 x 10^6) and nutrient media with fluorogenic substrate. Plastic vial packaging. Operates via enzyme-substrate fluorescence detection. Requires Celerity STEAM Incubator for readout. Complies with ISO 11138 standards for biological indicators.

Indications for Use

Indicated for monitoring and qualification testing of gravity steam sterilization cycles (270°F/132°C or 275°F/135°C for 3 or 10 minutes) in healthcare settings.

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 1491 Super Rapid Readout Biological Indicator (K103277)

Reference Devices

• Celerity 20 Steam Biological Indicator (K173634, K181686)

Submission Summary (Full Text)

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January 8, 2021

STERIS Corporation Anthony Piotrkowski Director, Regulatory Affairs 5976 Heislev Rd Mentor, Ohio 44060

Re: K202721

Trade/Device Name: Celerity 20 Steam Biological Indicator for IUSS Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: December 10, 2020 Received: December 11, 2020

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,

Clarence W. Murray III, Ph.D. Acting 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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## Indications for Use

510(k) Number (if known) K202721

### Device Name

Celerity 20 STEAM Biological Indicator for IUSS

Indications for Use (Describe) The Celerity 20 STEAM Biological Indicator for IUSS is used for monitoring and qualification testing of the following steam sterilization cycles: Gravity 270°F (132°C) 3 minutes Gravity 270°F (132°C) 10 minutes Gravity 275°F (135°C) 3 minutes Gravity 275°F (135°C) 10 minutes.

When used in conjunction with the Celerity STEAM Incubator provides a fluorescent result within 20 minutes.

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

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/14 description: The image shows the STERIS logo. The word "STERIS" is written in a serif font in all capital letters. Above the right side of the word STERIS is the registered trademark symbol. Below the word STERIS is a graphic of several horizontal wavy lines in blue.

# 510(k) Summary For Celerity 20 Steam Biological Indicator for IUSS

### Sponsor Facility

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

### Manufacturing Facility

STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Contact: Tony Piotrkowski Director, Regulatory Affairs

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

Submission Date: January 8, 2021

Premarket Notification number: K202721

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

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#### 1. Device Name

| Trade Name: | Celerity 20 Steam Biological Indicator for IUSS |
|------------------------|-----------------------------------------------------------------------|
| Common/usual Name: | Biological Indicator (BI, SCBI) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process<br>(21 CFR 880.2800, FRC) |

#### 2. Predicate Device

3M Attest 1491 Super Rapid Readout Biological Indicator, K103277

#### 3. Reference Device

Celerity 20 Steam Biological Indicator, cleared under K173634 and modified under K181686

#### 4. Description of Device

The product is intended to monitor the critical parameters of steam sterilization cycles described in the indications for use by producing an optical change (signal) that is detected by the STERIS proprietary reader, Celerity 20 Steam Incubator in 20 minutes to confirm the viability of the biological indicator at the end of a steam sterilization process. The product consists of a biological organism known to be resistant to steam (Geobacillus stearothermophilus) and a defined nutrient media. A reporter enzyme, which is produced by the native organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

#### Intended Use/ Indications for Use ട്.

The Celerity 20 STEAM Biological Indicator for IUSS is used for monitoring and qualification testing of the following steam sterilization cycles:

- Gravity 270°F (132°C) 3 minutes ●
- Gravity 270°F (132°C) 10 minutes ●
- Gravity 275°F (135°C) 3 minutes ●
- Gravity 275°F (135°C) 10 minutes.

When used in conjunction with the Celerity STEAM Incubator, the Incubator provides a fluorescent result within 20 minutes.

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### STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K202721 Celerity 20 Steam Biological Indicator for IUSS

#### Summary of Technical Characteristics 6.

A comparison of technical characteristics of the proposed device to the predicate are summarized in Table 5-1.

| | Celerity SCBI for IUSS<br>(proposed) | K103277 Attest 1491<br>(Predicate) | Comparison | Feature | Celerity SCBI for IUSS<br>(proposed) | K173634 Celerity 20<br>Steam BI (Reference) | Comparison |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | | | | Intended<br>Use | The Celerity 20 STEAM<br>Biological Indicator for<br>IUSS is used for monitoring<br>and qualification testing of<br>the following steam<br>sterilization cycles:<br>Gravity 270°F (132°C) 3<br>minutes<br>Gravity 270°F (132°C) 10<br>minutes<br>Gravity 275°F (135°C) 3<br>minutes<br>Gravity 275°F (135°C) 10<br>minutes.<br><br>When used in conjunction<br>with the Celerity STEAM<br>Incubator, the Incubator<br>provides a fluorescent result<br>within 20 minutes. | The Celerity 20 Steam<br>Biological Indicator (BI) is<br>for routine monitoring,<br>qualification testing and<br>product testing of the<br>following steam<br>sterilization processes:<br>270F, 4-minute dynamic<br>air removal; 275F, 3-<br>minute dynamic air<br>removal; 250 F, 30-minute<br>gravity; 270, 15-minutes<br>gravity.<br><br>When used in conjunction<br>with the Celerity 20 Steam<br>Incubator, the Celerity 20<br>Steam Biological Indicator<br>provides a fluorescent<br>result within 20 minutes. | Both are intended for<br>monitoring steam<br>sterilization cycles.<br><br>The Celerity BI for IUSS is<br>specifically for gravity IUSS<br>cycles. Testing is provided<br>in this 510(k) to demonstrate<br>suitable performance in<br>gravity IUSS cycles. |
| Intended<br>Use | The Celerity 20 STEAM<br>Biological Indicator for<br>IUSS is used for monitoring<br>and qualification testing of<br>the following steam<br>sterilization cycles:<br>Gravity 270°F (132°C) 3<br>minutes<br>Gravity 270°F (132°C) 10<br>minutes<br>Gravity 275°F (135°C) 3<br>minutes<br>Gravity 275°F (135°C) 10<br>minutes.<br>When used in conjunction<br>with the Celerity STEAM<br>Incubator, the Incubator<br>provides a fluorescent result<br>within 20 minutes. | Use 3M Attest 1491 Super<br>Rapid Read Biological<br>Indicator in conjunction<br>with the 3M Attest Auto-<br>reader 490 to monitor the<br>cycles below.<br>Gravity Displacement<br>IUSS (Flash):<br>270°F(132°C) 3 minutes;<br>270°F(132°C) 10 minutes;<br>275°F(135°C) 3 minutes;<br>275°F(135°C) 10 minutes.<br>The 3M Attest 1491 Super<br>Rapid Readout Biological<br>Indicator provides a final<br>fluorescent result in 30<br>minutes. An optional visual<br>pH color change result is<br>observed in 24 hours. | Both are intended for<br>monitoring the same steam<br>sterilization cycles.<br><br>The Celerity BI has a shorter<br>claimed readout time.<br>Reduced Incubation Time<br>(RIT) testing per the FDA<br>guidance demonstrates the<br>read time is appropriate. | Indicator<br>organism | > 90% similarity to ATCC<br>7953 Geobacillus<br>stearothermophilus | > 90% similarity to ATCC<br>7953 Geobacillus<br>stearothermophilus | Identical |
| Indicator<br>organism | > 90% similarity to ATCC<br>7953 Geobacillus<br>stearothermophilus | > 90% similarity to ATCC<br>7953 Geobacillus<br>stearothermophilus | Same criteria | Mechanism<br>of action | An enzyme, which is<br>produced by the organism,<br>reacts with a fluorogenic<br>substrate within the defined<br>nutrient media to produce a<br>fluorescent moiety | An enzyme, which is<br>produced by the organism,<br>reacts with a fluorogenic<br>substrate within the defined<br>nutrient media to produce a<br>fluorescent moiety | Identical |
| Mechanism<br>of action | An enzyme, which is<br>produced by the organism,<br>reacts with a fluorogenic<br>substrate within the defined<br>nutrient media to produce a<br>fluorescent moiety | An enzyme, which is<br>produced by the organism,<br>reacts with a fluorogenic<br>substrate within the defined<br>nutrient media to produce a<br>fluorescent moiety | Same mechanism | Accessories | Automated incubator /<br>reader | Automated incubator /<br>reader | Both use the same reader |
| Accessories | Automated incubator /<br>reader | Automated incubator /<br>reader | RIT testing performed with<br>the proposed<br>incubator/reader. | Viable spore<br>population | 1.0 - 4.0 x 106 spore/SCBI | 1.0 - 4.0 x 106 spore/SCBI | Identical |
| Viable spore<br>population | 1.0 - 4.0 x 106 spore/SCBI | ≥ 1.0 x 106 spore/SCBI | Both proposed and predicate<br>meet criteria of the FDA | Resistance | D132 ≥ 10 s<br>D135 ≥ 8 s | D121 ≥ 1.5 min<br>D132 ≥ 10 s<br>D135 ≥ 8 s | Identical at the two<br>temperatures for which the<br>proposed device is indicated |
| Resistance | D132 ≥ 10 s<br>D135 ≥ 8 s | D132 ≥ 10 s<br>D135 ≥ 8 s | guidance on Biological<br>Indicator 510(k) | Culture<br>Conditions | 55- 59 °C, media included<br>in SCBI, 20-minute<br>incubation time. | 55- 59 °C, media included<br>in SCBI, 20-minute<br>incubation time. | Identical |
| Culture<br>Conditions | 55- 59 °C, media included<br>in SCBI, 20-minute<br>incubation time. | 55- 59 °C, media included<br>in SCBI, 30 minute<br>incubation time. | RIT Testing and ISO 11138<br>media testing verifies<br>performance | Primary<br>Packaging | Direct inoculum on plastic<br>vial, cap with recovery<br>media. | Direct inoculum on plastic<br>vial, cap with recovery<br>media. | Identical |
| Primary<br>Packaging | Direct inoculum on plastic<br>vial, cap with recovery<br>media. | Inoculated paper in plastic<br>vial with cap and glass<br>ampoule with recovery<br>media in capped vial. | Similar configuration.<br>Component testing per ISO<br>11138-1 Annex B<br>demonstrates packaging is<br>compatible with indicator<br>and sterilization process. | | | | |

## Table 5-1. Proposed vs Predicate Physical Description and Technological Properties

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### STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K202721 Celerity 20 Steam Biological Indicator for IUSS

A comparison of technical characteristics of the proposed device to the predicate are summarized in Table 5-2.

### Table 5-2. Proposed vs Reference Physical Description and Technological Properties

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#### 7. Summary of Nonclinical Tests

Performance testing has been completed and is summarized in Table 5-2 below.

| Test | Acceptance Criteria | Conclusion |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Reduced<br>Incubation Time<br>(RIT) Testing | Meets FDA's requirement of $>$ 97%<br>alignment of the 20-minute results with the<br>conventional incubation time of 7 days | PASS |
| Viable spore<br>population | 1.0 - 4.0 x 106 spore/SCBI | PASS |
| Resistance | $D_{132} ≥ 10 s$<br>$D_{135} ≥ 8 s$ | PASS |
| Survival Time | Meets FDA requirements | $132 C ≥ 1 min$<br>$135 C ≥ 0.667 min$ |
| Carrier growth<br>inhibition / media<br>growth promotion | Positive growth of less than 100 spores after<br>primary packaging and media are subject to<br>worst case steam exposure | PASS |
| Hold Time | Performance not affected if incubated within<br>8 hours of exposure to steam sterilization | PASS |
| Simulated Use | Demonstrate growth when exposed to<br>abbreviated cycle and all kill in a full cycle | Abbreviated cycle - growth<br>Full cycle - no growth |
| Shelf-life | Population, resistance, RIT and media must<br>meet above criteria at each stability time<br>point | PASS at 3 months<br>(ongoing) |

### Table 5-2. Summary of Non-clinical Testing

#### 7. Conclusion

The conclusion drawn from the nonclinical tests performed demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K103277 Class II (21 CFR 880.2800, Product code FRC).