VERIFY Assert Self-Contained Biological Indicator

K181442 · STERIS Corporation · OWP · Jun 13, 2018 · General Hospital

Device Facts

• Record ID: K181442
• Device Name: VERIFY Assert Self-Contained Biological Indicator
• Applicant: STERIS Corporation
• Product Code: OWP · General Hospital
• Decision Date: Jun 13, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2805
• Device Class: Class 2

Intended Use

The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing and product testing of the following steam sterilization processes. Cycle Type Temperature Time Dynamic Air Removal 270°F (132°C) 4 minutes Dynamic Air Removal 275°F (135°C) 3 minutes Gravity 250°F (121°C) 30 minutes Gravity 270°F (132°C) 15 minutes When used in conjunction with the Reader for the VERIFY Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes

Device Story

Device is a self-contained biological indicator (SCBI) for steam sterilization monitoring. Contains Geobacillus stearothermophilus spores and nutrient media with a fluorogenic substrate. After sterilization, SCBI is placed in a proprietary reader (VERIFY Incubator). If sterilization is successful, spores are inactivated; if unsuccessful, surviving spores produce a reporter enzyme that reacts with the substrate to generate a fluorescent signal. Reader detects fluorescence within 40 minutes. Provides rapid confirmation of sterilization efficacy to healthcare personnel. Benefits include timely verification of sterilization process performance.

Clinical Evidence

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

Technological Characteristics

SCBI consists of Geobacillus stearothermophilus spores (1.0-4.0 x 10^6 per unit) and nutrient media with fluorogenic substrate in a plastic vial. Operates via enzymatic fluorescence detection. Incubation at 55-59°C for 40 minutes. Used with automated incubator/reader. Shelf-life 13 months.

Indications for Use

Indicated for routine monitoring, qualification testing, and product testing of steam sterilization processes (dynamic air removal and gravity cycles) in healthcare settings.

Regulatory Classification

Identification

A Recombinant-DNA plasmid biological indicator is intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization.

Predicate Devices

• VERIFY Assert Self-Contained Biological Indicator (K162701)

Reference Devices

• STERIS STEAM II (K113356)
• STERIS STEAM II (K112256)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains 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 text logo on the right. The FDA text logo is in blue and includes the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.

June 13, 2018

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

Re: K181442

Trade/Device Name: VERIFY Assert Self-Contained Biological Indicator Regulation Number: 21 CFR 880.2805 Regulation Name: Recombinant Biological Indicator Regulatory Class: Class II Product Code: OWP 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

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

K181442

801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 medical devices and radiation-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

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

# Indications for Use

510(k) Number (if known) K181442

### Device Name

VERIFY Assert Self-Contained Biological Indicator

Indications for Use (Describe)

The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing and product testing of the following steam sterilization processes.

| Cycle Type | Temperature | Time |
|---------------------|---------------|------------|
| Dynamic Air Removal | 270°F (132°C) | 4 minutes |
| Dynamic Air Removal | 275°F (135°C) | 3 minutes |
| Gravity | 250°F (121°C) | 30 minutes |
| Gravity | 270°F (132°C) | 15 minutes |

When used in conjunction with the Reader for the VERIFY Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 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)

### 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}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the STERIS logo. The word "STERIS" is in large, bold, black font at the top of the image. Below the word is a graphic of several horizontal wavy lines in blue. The "R" in STERIS has a circle around it, indicating that it is a registered trademark.

# 510(k) Summary For K181442 VERIFY Assert Self-Contained 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

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

#### 1. Device Name

| Trade Name: | VERIFY Assert Self-Contained Biological Indicator |
|------------------------|---------------------------------------------------------------------------------------------------|
| Common/usual Name: | Biological Indicator (BI, SCBI) |
| Device Classification: | Class II |
| Classification Name: | Biological Sterilization Process Indicator with<br>Recombinant-DNA Plasmid (21 CFR 880.2805, OWP) |

#### 2. Predicate Device

VERIFY Assert Self-Contained Biological Indicator, K162701

#### 3. 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, VERIFY Incubator for Assert Self-Contained Biological Indicator, in 40 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 organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

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

The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing and product testing of the following steam sterilization processes.

| Cycle Type | Temperature | Time |
|---------------------|---------------|------------|
| Dynamic Air Removal | 270°F (132°C) | 4 minutes |
| Dynamic Air Removal | 275°F (135°C) | 3 minutes |
| Gravity | 250°F (121°C) | 30 minutes |
| Gravity | 270°F (132°C) | 15 minutes |

When used in conjunction with the VERIFY Incubator for Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes.

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

#### Summary of Technical Characteristics ട.

| Feature | VERIFY Assert SCBI<br>K181442 | VERIFY Assert SCBI<br>Predicate (K162701) | Comparison |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Intended Use | The VERIFY Assert Self-<br>Contained Biological<br>Indicator (SCBI) is for<br>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>minnute dynamic air<br>removal; 250 F, 30-<br>minute gravity; 270, 15-<br>minutes gravity.<br>When used in conjunction<br>with the VERIFY<br>Incubator for Assert Self-<br>Contained Biological<br>Indicator, the VERIFY<br>Assert Self-Contained<br>Indicator provides a<br>fluorescent result within<br>40 minutes. | The VERIFY Assert Self-<br>Contained Biological<br>Indicator (SCBI) is for<br>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>minnute dynamic air<br>removal; 250 F, 30-<br>minute gravity; 270, 15-<br>minutes gravity.<br>When used in conjunction<br>with the VERIFY<br>Incubator for Assert Self-<br>Contained Biological<br>Indicator, the VERIFY<br>Assert Self-Contained<br>Indicator provides a<br>fluorescent result within<br>40 minutes. | Identical |
| Indicator<br>organism | > 90% similarity to ATCC<br>7953 Geobacillus<br>stearothermophilus | > 90% similarity to ATCC<br>7953 Geobacillus<br>stearothermophilus | Identical |
| Mechanism<br>of action | An enzyme, which is<br>produced by the indicator<br>organism, reacts with a<br>fluorogenic substrate<br>within the defined nutrient<br>media to produce a<br>fluorescent moiety. | An enzyme, which is<br>produced by the indicator<br>organism, reacts with a<br>fluorogenic substrate<br>within the defined nutrient<br>media to produce a<br>fluorescent moiety. | Identical |
| Accessories | Automated incubator /<br>reader | Automated incubator /<br>reader | Identical |
| Viable spore<br>population | 1.0 - 4.0 x 106 spore/BI | 1.0 – 4.0 x 106 spore/BI | Identical |
| Resistance<br>characteristics | D121 ≥ 1.5 min<br>D132 ≥ 10 s<br>D135 ≥ 8 s | D121 ≥ 1.5 min<br>D132 ≥ 10 s<br>D135 ≥ 8 s | Identical |
| Culture<br>Conditions | 55- 59 °C, media included<br>in SCBI, 40-minute<br>incubation time. | 55- 59 °C, media included<br>in SCBI, 40-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 | STERIS <span style="text-decoration: overline;">STEAM</span> II<br>(K113356) | STERIS <span style="text-decoration: overline;">STEAM</span> II<br>(K112256) | Identical |
| Feature | VERIFY Assert SCBI<br>K181442 | VERIFY Assert SCBI<br>Predicate (K162701) | Comparison |
| Label | Single-ply on cap edge | Two-ply on top of cap | Same adhesive and<br>substrate, different format<br>and location |
| Shelf-life | 13 months | 13 months | Identical |

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

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

#### 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<br>cycle with a worst-case load | No growth of BI |

#### 7. Conclusion

The VERIFY Assert Self-Contained 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, K162701 Class II (21 CFR 880.2805, Product code OWP).