VERIFY Assert Self-Contained Biological Indicator

• K Number: K181442
• Device Name: VERIFY Assert Self-Contained Biological Indicator
• Manufacturer: STERIS Corporation
• Date Cleared: 2018-06-13 ( 12 days)
• Product Code: OWP
• Regulation Number: 880.2805
• Type: Special
• Panel: General Hospital
• Reference & Predicate Devices: K162701
• Predicate For: N/A

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 Description

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.

AI/ML Overview

The provided document, a 510(k) premarket notification for the VERIFY Assert Self-Contained Biological Indicator, details the device's technical characteristics and nonclinical testing. However, it does not describe a study involving an AI-powered medical device or human readers. Therefore, much of the requested information cannot be extracted from this specific document.

Here's the information that can be extracted or inferred based on the document's content, formatted as requested:

1. A table of acceptance criteria and the reported device performance

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample size for the "Simulated Use" test, nor does it provide details about the data provenance (e.g., country of origin, retrospective/prospective). It only states that performance testing "has been completed" and is summarized.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a biological indicator for sterilization, not an imaging or diagnostic device requiring expert review for ground truth. The "ground truth" for this device's function is the biological outcome (growth or no growth of the biological indicator) after exposure to sterilization conditions.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There's no human interpretation or adjudication described for the biological indicator's performance. The outcome is a direct biological observation (fluorescence, indicating growth, or lack thereof).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document describes a biological indicator, not an AI-powered device or a study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a biological indicator. Its operation involves a "VERIFY Incubator for Assert Self-Contained Biological Indicator" which detects a fluorescent result, suggesting an automated readout. However, this is not an "algorithm only" performance in the context of AI without human-in-the-loop diagnosis or interpretation. The device itself is the indicator, and the incubator provides an automated reading of its state.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for this device's performance is the biological outcome: inactivation (no growth) of the Geobacillus stearothermophilus spores after exposure to sterilization conditions, or growth when not adequately sterilized. This is determined by observing fluorescence, which indicates enzymatic activity from viable spores.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device that requires a training set.

Summary

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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

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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

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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)

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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

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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 withRecombinant-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.

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Summary of Technical Characteristics ട.

Feature	VERIFY Assert SCBIK181442	VERIFY Assert SCBIPredicate (K162701)	Comparison
Intended Use	The VERIFY Assert Self-Contained BiologicalIndicator (SCBI) is forroutine monitoring,qualification testing andproduct testing of thefollowing steamsterilization processes:270F, 4-minute dynamicair removal; 275F, 3-minnute dynamic airremoval; 250 F, 30-minute gravity; 270, 15-minutes gravity.When used in conjunctionwith the VERIFYIncubator for Assert Self-Contained BiologicalIndicator, the VERIFYAssert Self-ContainedIndicator provides afluorescent result within40 minutes.	The VERIFY Assert Self-Contained BiologicalIndicator (SCBI) is forroutine monitoring,qualification testing andproduct testing of thefollowing steamsterilization processes:270F, 4-minute dynamicair removal; 275F, 3-minnute dynamic airremoval; 250 F, 30-minute gravity; 270, 15-minutes gravity.When used in conjunctionwith the VERIFYIncubator for Assert Self-Contained BiologicalIndicator, the VERIFYAssert Self-ContainedIndicator provides afluorescent result within40 minutes.	Identical
Indicatororganism	> 90% similarity to ATCC7953 Geobacillusstearothermophilus	> 90% similarity to ATCC7953 Geobacillusstearothermophilus	Identical
Mechanismof action	An enzyme, which isproduced by the indicatororganism, reacts with afluorogenic substratewithin the defined nutrientmedia to produce afluorescent moiety.	An enzyme, which isproduced by the indicatororganism, reacts with afluorogenic substratewithin the defined nutrientmedia to produce afluorescent moiety.	Identical
Accessories	Automated incubator /reader	Automated incubator /reader	Identical
Viable sporepopulation	1.0 - 4.0 x 106 spore/BI	1.0 – 4.0 x 106 spore/BI	Identical
Resistancecharacteristics	D121 ≥ 1.5 minD132 ≥ 10 sD135 ≥ 8 s	D121 ≥ 1.5 minD132 ≥ 10 sD135 ≥ 8 s	Identical
CultureConditions	55- 59 °C, media includedin SCBI, 40-minuteincubation time.	55- 59 °C, media includedin SCBI, 40-minuteincubation time.	Identical
PrimaryPackaging	Direct inoculum on plasticvial, cap with recoverymedia.	Direct inoculum on plasticvial, cap with recoverymedia.	Identical
Processindicator	STERIS STEAM II(K113356)	STERIS STEAM II(K112256)	Identical
Feature	VERIFY Assert SCBIK181442	VERIFY Assert SCBIPredicate (K162701)	Comparison
Label	Single-ply on cap edge	Two-ply on top of cap	Same adhesive andsubstrate, different formatand location
Shelf-life	13 months	13 months	Identical

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

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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-casecycle 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).

Regulation Number and Section

N/A