CELERITY 20 HP Biological Indicator

K181429 · STERIS Corporation · FRC · Jun 13, 2018 · General Hospital

Device Facts

• Record ID: K181429
• Device Name: CELERITY 20 HP Biological Indicator
• Applicant: STERIS Corporation
• Product Code: FRC · General Hospital
• Decision Date: Jun 13, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The CELERITY Biological Indicator is used for routine monitoring, and qualification of the Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Low Temperature Sterilizers in healthcare facilities. When used in conjunction with the VERIFY 20 HP Incubator, the CELERITY 20 HP Biological Indicator provides a fluorescent result within 20 minutes.

Device Story

Biological indicator for monitoring vapor-phase hydrogen peroxide sterilization cycles; consists of Geobacillus stearothermophilus spores and nutrient media in a plastic vial. Device functions by detecting reporter enzyme activity via fluorogenic substrate reaction; optical signal change measured by CELERITY 20 HP Incubator. Used in healthcare facilities by clinical staff to confirm sterilization efficacy. Output provides rapid (20-minute) fluorescent result indicating spore viability; informs healthcare providers on sterilization cycle success; ensures patient safety by verifying instrument sterility.

Clinical Evidence

Bench testing only. Simulated-use testing demonstrated that the biological indicator is inactivated when exposed to worst-case sterilization cycles and loads, with no growth observed.

Technological Characteristics

Plastic vial containing Geobacillus stearothermophilus spores and nutrient media. Sensing principle: fluorogenic enzyme-substrate reaction. Incubation conditions: 55-59°C. Connectivity: requires proprietary automated incubator/reader. Sterilization: vapor-phase hydrogen peroxide.

Indications for Use

Indicated for routine monitoring and qualification of specific V-PRO low-temperature sterilization cycles in healthcare facilities.

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 20 HP Biological Indicator (K172752)

Reference Devices

• VERIFY V-PRO Chemical Indicator (K140515)

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 13, 2018

STERIS Corporation Anthony Piotrkowski Senior Regulatory Affairs Manager 5960 Heisley Road Mentor, Ohio 44060

Re: K181429

Trade/Device Name: CELERITY 20 HP Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: May 30, 2018 Received: June 1, 2018

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Elizabeth F. Claverie -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K181429

Device Name Celerity 20 HP Biological Indicator

Indications for Use (Describe)

The CELERITY Biological Indicator is used for routine monitoring, and qualification of the Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Low Temperature Sterilizers in healthcare facilities.

When used in conjunction with the VERIFY 20 HP Incubator, the CELERITY 20 HP Biological Indicator 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/11 description: The image shows the STERIS logo. The word STERIS is in all caps and in a serif font. Below the word STERIS is an image of several horizontal wavy lines that are blue.

# 510(k) Summary For K181429 Celerity 20 HP Biological Indicator

### 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 Senior Manager, Regulatory Affairs

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

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

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#### 1. Device Name

| Trade Name: | Celerity 20 HP Biological Indicator |
|------------------------|--------------------------------------------------------------------|
| Common/usual Name: | Biological Indicator (BI, SCBI) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process (21 CFR 880.2800, FRC) |

### 2. Predicate Device

Celerity 20 HP Biological Indicator, K172752

### 3. Description of Device

The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, CELERITY 20 HP Incubator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

#### 4. Intended Use/ Indications for Use

The CELERITY Biological Indicator is used for routine monitoring, and qualification of the Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Low Temperature Sterilizers in healthcare facilities.

When used in conjunction with the VERIFY CELERITY 20 HP Incubator, the CELERITY 20 HP Biological Indicator provides a fluorescent result within 20 minutes.

#### 5. Summary of Technical Characteristics

A comparison of technical characteristics are summarized in Table 5-1.

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| Feature | CELERITY 20 HP BI<br>K181429 | CELERITY 20 HP BI<br>Predicate (K172752) | Comparison |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Intended Use | The CELERITY<br>Biological Indicator is<br>used for routine<br>monitoring, and<br>qualification of the Non<br>Lumen, Flexible, Lumen<br>and Fast Non Lumen<br>Cycles of the V-PRO 1, 1<br>Plus, maX, 60 and maX 2<br>Low Temperature<br>Sterilizers in healthcare<br>facilities.<br>When used in conjunction<br>with the VERIFY<br>CELERITY 20 HP<br>Incubator, the CELERITY<br>20 HP Biological Indicator<br>provides a fluorescent<br>result within 20 minutes. | The CELERITY<br>Biological Indicator is<br>used for routine<br>monitoring, and<br>qualification of the Non<br>Lumen, Flexible, Lumen<br>and Fast Non Lumen<br>Cycles of the V-PRO 1, 1<br>Plus, maX, 60 and maX 2<br>Low Temperature<br>Sterilizers in healthcare<br>facilities.<br>When used in conjunction<br>with the VERIFY<br>CELERITY 20 HP<br>Incubator, the CELERITY<br>20 HP Biological Indicator<br>provides a fluorescent<br>result within 20 minutes. | Identical |
| Indicator<br>organism | <i>Geobacillus<br/>stearothermophilus</i> | <i>Geobacillus<br/>stearothermophilus</i> | Identical |
| Mechanism<br>of action | An enzyme, which is<br>produced by the organism,<br>reacts with a fluorogenic<br>substrate within the<br>defined nutrient media to<br>produce a fluorescent<br>moiety. | An enzyme, which is<br>produced by the organism,<br>reacts with a fluorogenic<br>substrate within the<br>defined nutrient media to<br>produce a fluorescent<br>moiety. | Identical |
| Accessories | Automated incubator /<br>reader | Automated incubator /<br>reader | Identical |
| Viable spore<br>population | $1.0 - 4.0 \times 10^6$ spore/BI | $1.0 - 4.0 \times 10^6$ spore/BI | Identical |
| Resistance<br>characteristics | Resistance @ 9.1 mg/L<br>H2O2:<br>• D-value > 3 sec<br>• Survival Time ≥ 4 sec<br>• Kill Time ≤ 6 min | Resistance @ 9.1 mg/L<br>H2O2:<br>• D-value > 3 sec<br>• Survival Time ≥ 4 sec<br>• Kill Time ≤ 6 min | Identical |
| Culture<br>Conditions | 55- 59°C, media included<br>in BI, 20-minute<br>incubation time. | 55- 59°C, media included<br>in BI, 20-minute<br>incubation time. | Identical |
| 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 |
| Process<br>indicator | VERIFY V-PRO<br>Chemical Indicator<br>(K140515); magenta to<br>yellow color change. | VERIFY V-PRO<br>Chemical Indicator<br>(K140515); magenta to<br>yellow color change. | Identical |
| Label | Single-ply on cap edge | Two-ply on top of cap | Same adhesive and<br>substrate, different format<br>and location |
| Shelf-life | Currently 7 months | Currently 7 months | Real Time Testing Ongoing |

### Table 5-1. Summary of SCBI Physical Description and Technological Properties

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# K181429

#### Summary of Nonclinical Tests 6.

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-2 below.

Table 5-2. Summary of Non-clinical Testing

| Test | Acceptance Criteria | Result |
|---------------|-----------------------------------------------------------------------------|-----------------|
| Simulated Use | BI is inactivated when exposed in a worst-case cycle with a worst-case load | No growth of BI |

#### Conclusion 7.

The Celerity 20 HP Biological Indicator has met the established performance criteria. The conclusions drawn from the nonclinical tests performed demonstrate the subject device is as safe, as effective, and performs as well or better than the legally marketed predicate device, K172752 Class II (21 CFR 880.2800, Product code FRC).