VERIFY Assert Self-Contained Biological Indicator

• K Number: K162701
• Device Name: VERIFY Assert Self-Contained Biological Indicator
• Manufacturer: STERIS CORPORATION
• Date Cleared: 2017-03-24 ( 177 days)
• Product Code: OWP
• Regulation Number: 880.2805

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, Incubator for VERIFY Assert Self-Contained Biolgoical 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.

Predicate Devices

K102469, DEN110006

Reference Devices

K121484, K090569, K926364

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on biological and optical detection methods, with no mention of AI/ML algorithms for data analysis or interpretation.

Therapeutic

No.
This device is a biological indicator used to monitor the effectiveness of steam sterilization processes for medical devices, not to treat or diagnose patients.

Diagnostic

No

This device is a biological indicator used to monitor the effectiveness of steam sterilization processes, not to diagnose a medical condition in a patient.

SaMD (Software as a Medical Device)

No

The device is a biological indicator, which is a physical product containing biological material and media. It is used in conjunction with a hardware reader.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

• Intended Use: The device is intended for monitoring and testing steam sterilization processes. It assesses the effectiveness of a sterilization cycle, not to diagnose a disease or condition in a patient.
• Device Description: It uses a biological organism and nutrient media to indicate whether the sterilization process successfully killed the organism. This is a quality control measure for a sterilization process, not a diagnostic test performed on a biological sample from a patient.
• Anatomical Site and Patient Age Range: These are listed as "Not Applicable," which is consistent with a device used for process monitoring rather than patient diagnosis.
• Intended User / Care Setting: While used by healthcare providers, the context is within the sterilization process, not directly for patient diagnosis or treatment based on a biological sample.

IVDs are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such a function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 Reader for the VERIFY Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes.

Product codes

OWP

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, Incubator for VERIFY Assert Self-Contained Biolgoical 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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

Test	Acceptance Criteria	Conclusion
Reduced Incubation Time (RIT) Testing	> 97% alignment of the 40-minute results with the conventional incubation time of 7 days	PASS
Viable spore population	1.0 - 4.0 x 10 spore/SCBI	1.6 - 1.9 x 106 spore/SCBI
Resistance	D121 ≥ 1.5 min D132 ≥ 10 s D135 ≥ 8 s	D121 ≥ 2.29 min D132 ≥ 49 s D135 ≥ 40 s
Survival Time	Meets the longer of FDA and ISO 11138-3 requirements	121 C ≥ 9.81 min 132 C ≥ 3.51 min 135 C ≥ 2.83 min
Kill Time	Meets the shorter of FDA and ISO 11138-3 requirements	121 C ≤ 25.57 min 132 C ≤ 9.21 min 135 C ≤ 7.73 min
Carrier growth inhibition / media growth promotion	Positive growth of less than 100 spores after primary packaging and media are subject to worst case steam exposure	PASS
Hold Time	Performance not affected if incubated within 72 hours of exposure to steam sterilization	PASS
Simulated Use	Demonstrate growth when exposed to abbreviated cycle and all kill in a full cycle	Abbreviated cycle - growth Full cycle - no growth
Process indicator	Meets requirements for a “Class 1” process indicator of ISO 11140-1:2005	PASS Testing provided in K112256

Key Metrics

Not Found

Predicate Device(s)

K102469/DEN110006

Reference Device(s)

K121484, K090569, K926364

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 24, 2017

STERIS Corporation Mr. Anthony Piotrkowski Senior Manager, Regulatory Affairs 5960 Heisley Rd. Mentor, Ohio 44060

Re: K162701

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: February 17, 2017 Received: February 21, 2017

Dear Mr. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Ryan -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) K162701

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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510(k) Summary For K162701 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]

Tony Piotrkowski Contact: Senior Manager, Regulatory Affairs

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

Submission Date: March 15, 2017

Premarket Notification Number: K162701

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:	Recombinant Biological Indicator (21 CFR 880.2805, OWP)

2. Predicate Device

VERIFY CRONOS Self-Contained Biological Indicator K102469/DEN110006

Reference Devices

3M Attest Super Rapid Readout Biological Indicator, Model 1492 K121484 Attest Rapid Readout Biological Indicator, Model 1292 K090569 Attest Rapid Readout Biological Indicator, Model 1291 K926364

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, Incubator for VERIFY Assert Self-Contained Biolgoical 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

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K162701/S001 STERIS Response to 11/23/16 Request for Additional Information VERIFY Assert Self-Contained Biological Indicator

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.

5. Summary of Technical Characteristics

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

Feature	Assert SCBI	VERIFY Cronos SCBI
	(proposed -K162701)	(predicate-K102469)	Comparison
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:
270F, 4-minute dynamic
air removal; 275F, 3-
minute dynamic air
removal; 250 F, 30 minute
gravity; 270, 15-minutes
gravity.
When used in conjunction
with the Reader for the
VERIFY Assert Self-
Contained Incubator, the
VERIFY Assert Self-
Contained Indicator
provides a fluorescent
result within 40 minutes.	For use by health care
providers for qualification
and routine monitoring of
steam sterilization
processes. The VERIFY
Cronos SCBI is only
validated to be used in the
following steam
sterilization cycles:
132 C vacuum-assisted
steam with 4-minute
sterilization time; 135 C
vacuum-assisted steam with
3-minute sterilization time;
121 C gravity steam with
30-minute sterilization
time; 132 C gravity steam
with 15-minute
sterilization time; 135 C
gravity steam with 10-
minute sterilization time;
132 C Steam Flush Press
ure Pulse with 4- minute
sterilization time.	Both are intended for
monitoring steam
sterilization cycles.
Use statement for the
proposed device has been
aligned with AAMI ST79,
Table 6 recommendations
for use of BI.
The Assert SCBI is claiming
different cycles compared to
the predicate (no 10-minute
135 gravity adding 135
SFPP). Simulated use
testing in sterilizers with a
load under pass and fail
conditions demonstrate
performance of the Assert
SCBI in these additional
cycles.
Indicator
organism	> 90% similarity to ATCC
7953 Geobacillus
stearothermophilus	> 90% similarity to ATCC
7953 Geobacillus
stearothermophilus	Same
Mechanism
of action	An enzyme, which is
produced by the indicator
organism, reacts with a
fluorogenic substrate
within the defined nutrient
media to produce a
fluorescent moiety	An enzyme, which is
produced by the plasmid,
reacts with a fluorogenic
substrate within the defined
nutrient media to produce a
fluorescent moiety	Same mechanism of action,
testing provided
demonstrates conformance
with ISO 11138 and the
FDA guidance on BI
submissions
Accessories	Automated incubator /
reader	Automated incubator /
reader	RIT testing performed with
the proposed
incubator/reader.
Viable spore
population	1.0 - 4.0 x 106 spore/SCBI	1.0 - 5.0 x 106 spore/SCBI	Proposed population range
within that of the predicate
and both meet FDA
guidance and ISO 11138
requirements
Feature	Assert SCBI
(proposed -K162701)	VERIFY Cronos SCBI
(predicate-K102469)	Comparis on
Resistance	$D_{121} ≥ 1.5$ min
$D_{132} ≥ 10$ s
$D_{135} ≥ 8$ s	121°C - 1.5 to 3.0 min
132°C - 10 to 30 sec
134°C - 8 sec to 20 sec
135°C - 8 sec to 20 sec	Both proposed and predicate
meet criteria of ISO 11138-3
and FDA guidance
Culture
Conditions	55- 59 °C, media included
in SCBI, 40 minute
incubation time.	55- 59 °C, media included
in SCBI, 120 minute
incubation time.	RIT Testing and ISO 11138
media testing verifies
performance
Primary
Packaging	Direct inoculum on plastic
vial, cap with recovery
media.	Inoculated paper in plastic
vial with cap and glass
ampoule with recovery
media in capped vial.	Similar configuration.
Component testing per ISO
11138-1 Annex B
demons trates packaging is
compatible with indicator
and sterilization process.
Process
indicator	STERIS STEAM Π
(K112256)	STERIS STEAM Π
(K112256)	Same indicator on both
products

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

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K162701/S001 STERIS Response to 11/23/16 Request for Additional Information VERIFY Assert Self-Contained Biological Indicator

6. Summary of Nonclinical Tests

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

Test	Acceptance Criteria	Conclusion
Reduced
Incubation Time
(RIT) Testing	Meets FDA's requirement of > 97%
alignment of the 40-minute results with the
conventional incubation time of 7 days	PASS
Viable spore
population	1.0 - 4.0 x 10 spore/SCBI	1.6 - 1.9 x 106 spore/SCBI
Resistance	D121 ≥ 1.5 min
D132 ≥ 10 s
D135 ≥ 8 s	D121 ≥ 2.29 min
D132 ≥ 49 s
D135 ≥ 40 s
Survival Time	Meets the longer of FDA and ISO 11138-3
requirements	121 C ≥ 9.81 min
132 C ≥ 3.51 min
135 C ≥ 2.83 min
Kill Time	Meets the shorter of FDA and ISO 11138-3
requirements	121 C ≤ 25.57 min
132 C ≤ 9.21 min
135 C ≤ 7.73 min
Carrier growth
inhibition / media
growth promotion	Positive growth of less than 100 spores after
primary packaging and media are subject to
worst case steam exposure	PASS
Hold Time	Performance not affected if incubated
within 72 hours of exposure to steam
sterilization	PASS
Simulated Use	Demonstrate growth when exposed to
abbreviated cycle and all kill in a full cycle	Abbreviated cycle -
growth
Full cycle - no growth

Table 5-2. Summary of Non-clinical Testing

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K162701/S001 STERIS Response to 11/23/16 Request for Additional Information VERIFY Assert Self-Contained Biological Indicator

Test	Acceptance Criteria	Conclusion
Process indicator	Meets requirements for a “Class 1” process
indicator of ISO 11140-1:2005	PASS
Testing provided in
K112256

7. Conclusion

The VERIFY Assert Self-Contained Biological Indicator has met the established performance criteria. The results of the studies demonstrate that the biological indicator performs as intended, and based on the nonclinical tests performed, the subject device is substantially equivalent and is as safe and as effective as the legally marketed predicate device Class II (21 CFR 880.2805, Product code OWP).