VERIFY Incubator for Assert Self Contained Biological Indicators

• K Number: K163587
• Device Name: VERIFY Incubator for Assert Self Contained Biological Indicators
• Manufacturer: STERIS Corporation
• Date Cleared: 2017-03-24 ( 94 days)
• Product Code: OWP
• Regulation Number: 880.2805

Intended Use

Use the VERIFY® Incubator for Assert™ Self Contained Biological Indicators SCBI (Incubator) to incubate and automatically read VERIFY Assert Self-Contained Biological Indicators at 57 °C for a fluorescent result within 40 minutes.

Device Description

The VERIFY® Incubator for Assert™ Self Contained Biological Indicators (Incubator) is an incubator/reader designed for use specifically with the VERIFY Assert Self-Contained Biological Indicator (SCBI), see K162701, currently under review. The incubator/reader provides a constant temperature range to allow for activation and outgrowth of Geobacillus stearothermophilus leading to production of a fluorescent moiety. The presence of an increasing fluorescence signal due to increasing concentrations of this fluorescent moiety in the SCBI is detected by the incubator/reader and indicates the presence of viable test microorganisms.

Predicate Devices

K102469/DEN110006

Reference Devices

K123546

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on temperature control and fluorescence detection, with no mention of AI or ML algorithms for analysis or interpretation.

Therapeutic

No
This device is an incubator/reader for biological indicators used to assess the effectiveness of sterilization processes, not to directly diagnose, treat, or prevent disease in humans.

Diagnostic

No

This device is an incubator/reader for biological indicators used to assess the effectiveness of sterilization processes, not to diagnose a medical condition in a patient.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "incubator/reader" and describes hardware components like a temperature control system and a fluorescence detection system.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The device is used to incubate and read biological indicators (SCBIs) to determine the presence of viable microorganisms. This process is performed in vitro (outside of a living organism) to assess the effectiveness of sterilization processes.
• Device Description: It describes the device's function in detecting a fluorescent signal produced by the growth of microorganisms within the SCBI. This detection is a diagnostic step to determine the success or failure of sterilization.
• Performance Studies: The performance studies focus on the device's ability to accurately read the SCBIs and align with traditional growth results, which is a key aspect of validating an IVD.
• Predicate Device: The predicate device (VERIFY CRONOS SCBI) is also an SCBI reader, which are typically classified as IVDs.

The device is designed to analyze a sample (the biological indicator) in vitro to provide information about the effectiveness of a sterilization process, which directly fits the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Use the VERIFY® Incubator for Assert™ Self Contained Biological Indicators SCBI (Incubator) to incubate and automatically read VERIFY Assert Self-Contained Biological Indicators at 57 °C for a fluorescent result within 40 minutes.

Product codes

OWP

Device Description

The VERIFY® Incubator for Assert™ Self Contained Biological Indicators (Incubator) is an incubator/reader designed for use specifically with the VERIFY Assert Self-Contained Biological Indicator (SCBI), see K162701, currently under review. The incubator/reader provides a constant temperature range to allow for activation and outgrowth of Geobacillus stearothermophilus leading to production of a fluorescent moiety. The presence of an increasing fluorescence signal due to increasing concentrations of this fluorescent moiety in the SCBI is detected by the incubator/reader and indicates the presence of viable test microorganisms.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 3 below.

Test	Acceptance Criteria	Conclusion
Maintenance of Incubation Temperature	Maintain 55-60 °C for a minimum of 40 minutes (incubation time of Verify Assert SCBI as stated in K162701)	PASS
Qualification testing with Verify Assert SCBI	40-minute fluorescent read meets >97% alignment with 7-day growth results per FDA guidance on reduced incubation time.	PASS
Qualification testing with Verify Assert SCBI	Pass testing with SCBI exposed to full cycle exposure and negative growth result in incubator	PASS
Qualification testing with Verify Assert SCBI	Fail testing with SCBI exposed in abbreviated cycle exposure and positive result in incubator	PASS
Alarm, LED and Print function Test	Demonstrate proper function of alarms, LED and print outputs	PASS

The results of the studies demonstrate that the biological indicator performs as intended.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K102469/DEN110006

Reference Device(s)

K123546

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 Anthony Piotrkowski Senior Regulatory Affairs Manager 5976 Heisley Rd Mentor, Ohio 44060

Re: K163587

Trade/Device Name: Verify Incubator For Assert Self Contained Biological Indicators 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 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 devicerelated 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.

1

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/ResourcesforYou/Industry/default.htm. 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 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

2

Indications for Use

510(k) Number (if known) K163587

Device Name

VERIFY® Incubator for Assert™ Self Contained Biological Indicators

Indications for Use (Describe)

Use the VERIFY® Incubator for Assert™ Self Contained Biological Indicators SCBI (Incubator) to incubate and automatically read VERIFY Assert Self-Contained Biological Indicators at 57 °C for 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 K163587 VERIFY® Incubator for Assert™ Self-Contained Biological Indicators

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: Anthony Piotrkowski

Telephone: [phone] Fax No: [phone] e-mail: tony piotrkowski(@steris.com

Submission Date: March 22, 2017

510(k) Number: K163587

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

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1. Device Name

| Trade Name: | VERIFY® Incubator for Assert™ Self Contained
Biological Indicators |
|------------------------|-----------------------------------------------------------------------|
| Common/usual Name: | Incubator/Reader (accessory to Biological Indicator) |
| Device Classification: | Class II |
| Classification Name: | Recombinant Biological Indicator
(21 CFR 880.2805, OWP) |

2. Predicate Device

VERIFY CRONOS SCBI K102469/DEN110006

Reference Device: 3M Attest 390 Auto-reader K123546

3. Description of Device

The VERIFY® Incubator for Assert™ Self Contained Biological Indicators (Incubator) is an incubator/reader designed for use specifically with the VERIFY Assert Self-Contained Biological Indicator (SCBI), see K162701, currently under review. The incubator/reader provides a constant temperature range to allow for activation and outgrowth of Geobacillus stearothermophilus leading to production of a fluorescent moiety. The presence of an increasing fluorescence signal due to increasing concentrations of this fluorescent moiety in the SCBI is detected by the incubator/reader and indicates the presence of viable test microorganisms.

4. Intended Use/ Indications for Use

Use the VERIFY® Incubator for Assert™ Self Contained Biological Indicators SCBI (Incubator) to incubate and automatically read VERIFY Assert Self-Contained Biological Indicators at 57 °C for a fluorescent result within 40 minutes.

5. Summary of Technical Characteristics

A comparison of technical characteristics are summarized in Tables 1 and 2.

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| Feature | VERIFY Incubator for
Assert SCBI
(proposed) | VERIFY CRONOS
SCBI
(K102469/DEN110006)
Predicate | Comparison |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Use the VERIFY®
Incubator for Assert™ Self
Contained Biological
Indicators SCBI
(Incubator) to incubate and
automatically read
VERIFY Assert Self-
Contained Biological
Indicators at 57 °C for a
fluorescent result within
40 minutes. | The Verify Cronos Self-
Contained Biological
Indicator for Steam
Sterilization Processes is
intended for use by health
care providers as a
standard method to
monitor steam sterilization
processes. The Verify
Cronos is validated to be
used in the following
steam sterilization cycles:
1.) Standard Prevac
270°F/132°C for 4 minutes
2.) Standard Prevac
275°F/135°C for 3 minutes
3.) Standard Gravity
250°F/121°C for 30 minutes
4.) Standard Gravity
270°F/132°C for 15 minutes
5.) Standard Gravity
275°F/135°C for 10 minutes
6.) Standard SFPP
270°F/132°C for 4
minutes | The predicate incubator was
an accessory to the
Biological Indicator and did
not have its own intended
use or indications for use.
The proposed device is an
accessory to the VERIFY
Attest SCBI. |
| Basis of
Readout | Photodiode detects
fluorescence produced by
enzymatic activity that
results from growing
biological indicator
organisms | Photodiode detects
fluorescence produced by
enzymatic activity that
results from growing
biological indicator
organisms | Same |
| Incubation
Temperature
Range | 55 - 60 °C | 55 - 60 °C | Same |
| Voltage Range | 90 to 264 VAC with 12
VDC conversion. | 90 to 264 VAC with 12
VDC conversion. | Same |
| Test capacity | 8 wells | 8 wells | Same |
| Calibration | Factory calibration - no
calibration by customer | Factory calibration - no
calibration by customer | Same |
| Incubation
Time | 40 minutes | 40 minutes | Same |
| Feature | VERIFY Incubator for
Assert SCBI
(proposed) | VERIFY CRONOS
SCBI
(K102469/DEN110006)
Predicate | Comparison |
| Fluorescence
Detection | Active enzyme from the
spores cleaves the
fluorogenic substrate
contained within the
SCBI's media to produce a
fluorescent molecule. | Active enzyme from the
spores cleaves the
fluorogenic substrate
contained within the
SCBI's media to produce a
fluorescent molecule. | Same |
| Indication of
Results | Positive - audible alarm,
visual LED lights and
screen
Negative - no alarm,
visual indication with
LED lights and LCD
screen
User must acknowledge
results | Positive - audible alarm,
visual LED lights and
screen
Negative - no alarm,
visual indication with
LED lights and LCD
screen
User must acknowledge
results | Same |
| Compliance | Electrical Safety and EMC
Testing
• IEC 61010-1 (2010)
Third Ed
• IEC 61010-2-010
(2013) Third Ed
Electromagnetic
compatibility
• USA Title 47, Code
of Federal
Regulations (2007)
for:
• Radiated Emissions
(FCC Part 15,
Subpart B, Class A)
• Conducted
Emissions (FCC
Part 15, Subpart B,
Class A)
• IEC 61326:2013 -
• EN 55011:2009, Inc.
A1:2010
• EN 61000-3-2:2006,
Inc. A1:2009 and
A2:2009
EN 61000-3-3-2013 | Electrical Safety and EMC
Testing
• IEC 61010-1 second
Ed
• IEC 61010-2-010
Second Ed
Electromagnetic
compatibility
• USA Title 47, Code
of Federal
Regulations (2007)
for:
• Radiated Emissions
(FCC Part 15,
Subpart B, Class A)
• Conducted
Emissions (FCC
Part 15, Subpart B,
Class A)
• IEC 61326:
• EN 55011:
• EN 61000-3-2:2006,
Inc. A1:2009 and
A2:2009
EN 61000-3-3 | Both meet applicable
electrical safety standards |
| Feature | VERIFY Incubator for
Assert SCBI
(proposed) | VERIFY CRONOS
SCBI
(K102469/DEN110006)
Predicate | Comparison |
| System
Operation | The reader/incubator wells
are arranged in 2 banks of
4 wells and preset to 57°C.
The measurement of
fluorescence is initiated by
placement of a VERIFY
Assert SCBI into any of
the incubation wells and
pressing the adjacent
"ACTION" button.
When an SCBI is placed
into a well, the auto-reader
detects its presence. Upon
pressing the button
associated with that well, a
blinking yellowish light
indicates that incubation is
in process and the read
initiated.
A "positive" reading is
interpreted as an
indication of a potential
sterilization cycle failure.
A "positive" finding is
indicated to the user by
red light on the front panel
adjacent to the well, by an
audible alarm, and by text
displayed on the LCD
screen. The alarm must be
muted by the operator
when a positive result is
obtained. The LCD screen
provides instructions for
the user to turn off the
alarm for that specific
SCBI.
Should another BI become
"positive", the alarm will
sound again and the above
actions are repeated.
If the result is not positive
at the end of the
incubation time, the result
is negative. Negative
results are identified by a
green light on the front
panel adjacent to the well
with the "negative" BI and
by text on the LCD. | The reader/incubator wells
are arranged in 2 banks of
4 wells and preset to 57°C.
The measurement of
fluorescence is initiated by
placement of a VERIFY
Assert SCBI into any of
the incubation wells and
pressing the adjacent
"ACTION" button.
When an SCBI is placed
into a well, the auto-reader
detects its presence. Upon
pressing the button
associated with that well, a
blinking yellowish light
indicates that incubation is
in process and the read
initiated.
A "positive" reading is
interpreted as an
indication of a potential
sterilization cycle failure.
A "positive" finding is
indicated to the user by
red light on the front panel
adjacent to the well, by an
audible alarm, and by text
displayed on the LCD
screen. The alarm must be
muted by the operator
when a positive result is
obtained. The LCD screen
provides instructions for
the user to turn off the
alarm for that specific
SCBI.
Should another BI become
"positive", the alarm will
sound again and the above
actions are repeated.
If the result is not positive
at the end of the
incubation time, the result
is negative. Negative
results are identified by a
green light on the front
panel adjacent to the well
with the "negative" BI and
by text on the LCD. | Same |

Table 1 Summary of Incubator Physical Description and Technological Properties vs Predicate

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7

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Table 2 Summary of Incubator Physical Description and Technological Properties vs Reference Device

| Feature | VERIFY Incubator for
Assert SCBI
(proposed) | Attest 390
(K123546) Reference | Comparison |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Use the VERIFY®
Incubator for Assert™ Self
Contained Biological
Indicators SCBI
(Incubator) to incubate and
automatically read
VERIFY Assert Self-
Contained Biological
Indicators at 57 °C for a
fluorescent result within
40 minutes. | The 3M Attest 390 Auto-
reader is designed to
incubate and automatically
read the 3M Attest Rapid
readout Biological
indicators for Steam 1291,
1292, at 60 °C for a final
fluorescent result at 1 hour
for 1291 and 3 hours for
1292. | Both are intended for
incubation and automatic
reading of specific self-
contained biological
indicators. |
| Basis of
Readout | Photodiode detects
fluorescence produced by
enzymatic activity that
results from growing
biological indicator
organisms | Photodiode detects
fluorescence produced by
enzymatic activity that
results from growing
biological indicator
organisms | Same |
| Incubation
Temperature
Range | 55 - 60 °C | 60 ± 2 °C | Both operate within the
growth temperature range of
Geobacillus
stearothermophilus |
| Voltage Range | 90 to 264 VAC with 12
VDC conversion. | 100-240 VAC with 12
VDC conversion. | Similar range and same
operating voltage. Electrical
safety testing demonstrates
suitability. |
| Test capacity | 8 wells | 10 wells | Both can accommodate
multiple samples |
| Calibration | Factory calibration - no
calibration by customer | Factory calibration - no
calibration by customer | Same |
| Incubation
Time | 40 minutes | 1 hour (1291), 3 hours
(1292) | Reduced incubation time
testing in accordance with
FDA guidance is provided in
this submission |
| Fluorescence
Detection | Active enzyme from the
spores cleaves the
fluorogenic substrate
contained within the
SCBI's media to produce a
fluorescent molecule. | UV LEDs are used to
excite the fluorescent
molecule produced by
enzyme cleavage of the
fluorogenic substrate
contained in the SCBI's
media. The emitted light
is detected by a
photodiode. | Similar Detection Method -
photodiode sensors |
| Feature | VERIFY Incubator for
Assert SCBI
(proposed) | Attest 390
(K123546) Reference | Comparison |
| System
Operation | The reader/incubator wells
are arranged in 2 banks of
4 wells and preset to 57°C.
The measurement of
fluorescence is initiated by
placement of a VERIFY
Assert SCBI into any of
the incubation wells and
pressing the adjacent
"ACTION" button.
When an SCBI is placed
into a well, the auto-reader
detects its presence. Upon
pressing the button
associated with that well, a
blinking yellowish light
indicates that incubation is
in process and the read
initiated.
A "positive" reading is
interpreted as an
indication of a potential
sterilization cycle failure.
A "positive" finding is
indicated to the user by
red light on the front panel
adjacent to the well, by an
audible alarm, and by text
displayed on the LCD
screen. The alarm must be
muted by the operator
when a positive result is
obtained. The LCD screen
provides instructions for
the user to turn off the
alarm for that specific
SCBI.
Should another BI become
"positive", the alarm will
sound again and the above
actions are repeated.
If the result is not positive
at the end of the
incubation time, the result
is negative. Negative
results are identified by a
green light on the front
panel adjacent to the well
with the "negative" BI and
by text on the LCD. | The measurement of
fluorescence is initiated by
placement of an Attest
SCBI into any of the
incubation wells. The
reader/incubator wells are
color-coded to match the
color of the top of the
SCBIs. The incubator
block may be color coded.
When a BI is placed into a
well, its presence is
detected. The LCD screen
below the SCBI shows the
time remaining to
complete the incubation
period.
Detection of a positive
result is indicated by a '+'
sign on the LCD screen,
accompanied by an
audible alarm. A positive
result is indicative of a
sterilization cycle failure.
The alarm must be muted
by the operator when a
positive result is obtained.
Pressing the mute button
disables the alarm only for
the specific SCBI which
was just identified as
positive. Should another
BI become "positive", the
alarm will again sound.
If the result is not positive
at the end of the
incubation time, the result
is negative. Negative
results are identified by a
'- 'sign on the LCD
screen. | Both have similar modes of
operation only type of
biological indicator is
intended for use with the
proposed device so no color
coding is required and both
alarm for a positive BI. |
| Feature | VERIFY Incubator for
Assert SCBI
(proposed) | Attest 390
(K123546) Reference | Comparison |
| Indication of
Results | Positive - audible alarm,
visual LED lights and
screen
Negative - no alarm,
visual indication with
LED lights and LCD
screen
User must acknowledge
results | Positive - audible alarm
(if enabled), "+" indication
on LCD panel, and
flashing of LCD panel
backlighting
Negative - no alarm, "-
"indication on LCD panel | Similar Indication of Results |
| Compliance | Electrical Safety and EMC
Testing
IEC 61010-1 (2010)
Third Ed IEC 61010-2-010
(2013) Third Ed Electromagnetic
compatibility USA Title 47, Code
of Federal
Regulations (2007)
for: Radiated Emissions
(FCC Part 15,
Subpart B, Class A) Conducted
Emissions (FCC
Part 15, Subpart B,
Class A) IEC 61326:2013 - EN 55011:2009, Inc.
A1:2010 EN 61000-3-2:2006,
Inc. A1:2009 and
A2:2009 EN 61000-3-3:2013 | Electrical Safety and EMC
Testing IEC 61010-1 (2001)
Second Ed IEC 61010-2-010
(2003) Second Ed Electromagnetic
compatibility USA Title 47, Code
of Federal
Regulations (2009)
for: Radiated Emissions
(FCC Part 15,
Subpart B, Class
A) Conducted
Emissions (FCC
Part 15, Subpart B,
Class A) IEC 61326: | Both meet relevant electrical
standards for safety,
emissions and compatibility
that were active at time of
submission. |

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6. Summary of Nonclinical Tests

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 3 below.

Test	Acceptance Criteria	Conclusion
Maintenance of
Incubation
Temperature	Maintain 55-60 °C for a minimum of 40 minutes
(incubation time of Verify Assert SCBI as stated
in K162701)	PASS
Qualification testing
with Verify Assert
SCBI	40-minute fluorescent read meets >97%
alignment with 7-day growth results per FDA
guidance on reduced incubation time.	PASS

Table 3. Summary of Non-clinical Testing

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Test	Acceptance Criteria	Conclusion
Qualification testing
with Verify Assert
SCBI	Pass testing with SCBI exposed to full cycle
exposure and negative growth result in incubator	PASS
	Fail testing with SCBI exposed in abbreviated
cycle exposure and positive result in incubator	PASS
Alarm, LED and
Print function Test	Demonstrate proper function of alarms, LED and
print outputs	PASS

7. Conclusion

The VERIFY® Incubator for Assert™ Self-Contained BI's 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).