VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator

• K Number: K171587
• Device Name: VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator
• Manufacturer: Steris Corporation
• Date Cleared: 2017-08-22 ( 83 days)
• Product Code: FRC
• Regulation Number: 880.2800

Intended Use

Use the VERIFY Incubator for Assert VH2O2 Self Contained Biological Indicators (Incubator) to incubate and automatically read VERIFY Assert VH2O2 Self-Contained Biological Indicators at 57 °C for a fluorescent result within 20 minutes.

Device Description

VERIFY® Incubator for Assert™ | VH2O2 Self Contained Biological Indicators (Incubator) is an incubator/reader designed for use specifically with the VERIFY Assert |VH2O2| Self-Contained Biological Indicator (SCBI), subject of a concurrent submission, K171504, currently under review. The incubator/reader provides a constant temperature range to allow for activation and outgrowth of Geobacillus stearothermophilus leading to production of an endogenous 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

K123546

Reference Devices

K163587

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on temperature control and fluorescent signal detection, with no mention of AI/ML terms or capabilities.

Therapeutic

No.
The device is an incubator and reader for biological indicators used to assess the efficacy of sterilization processes, not to treat any medical condition or directly interact with a patient.

Diagnostic

No

The device is an incubator/reader for biological indicators used to assess the effectiveness of sterilization processes. It determines the presence of viable microorganisms in the biological indicator, not a diagnostic condition in a patient.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "incubator/reader" and describes hardware functions like maintaining temperature and detecting fluorescence, indicating it is a physical device, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use clearly states it's for "incubate and automatically read VERIFY Assert VH2O2 Self-Contained Biological Indicators". Biological indicators are used to monitor the effectiveness of sterilization processes, which is a critical part of ensuring the safety of medical devices and preventing infections. This falls under the scope of in vitro diagnostics as it's testing a biological sample (the biological indicator) outside of the body to provide information relevant to healthcare.
• Device Description: The description explains that it detects the presence of viable microorganisms (Geobacillus stearothermophilus) in the biological indicator by detecting a fluorescent signal. This is a diagnostic test performed in vitro.
• Performance Studies: The performance studies focus on the device's ability to accurately read the biological indicators and align with 7-day growth results, which is a standard method for validating the performance of biological indicators and their readers.
• Predicate Device: The predicate device is the "3M Attest 390 Auto-reader", which is a known IVD device used for reading biological indicators.

While the text doesn't explicitly use the term "IVD", the function and purpose of the device, as described in the intended use and device description, align with the definition of an in vitro diagnostic device. It's a device used to examine a biological sample (the biological indicator) outside of the body to provide information relevant to healthcare (the effectiveness of a sterilization process).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Use the VERIFY Incubator for Assert VH2O2 Self Contained Biological Indicators (Incubator) to incubate and automatically read VERIFY Assert VH2O2 Self-Contained Biological Indicators at 57 °C for a fluorescent result within 20 minutes.

Product codes (comma separated list FDA assigned to the subject device)

FRC

Device Description

VERIFY® Incubator for Assert™ | VH2O2 Self Contained Biological Indicators (Incubator) is an incubator/reader designed for use specifically with the VERIFY Assert |VH2O2| Self-Contained Biological Indicator (SCBI), subject of a concurrent submission, K171504, currently under review. The incubator/reader provides a constant temperature range to allow for activation and outgrowth of Geobacillus stearothermophilus leading to production of an endogenous 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 5-3 below.
Tests performed:

• Maintenance of Incubation Temperature: Maintain 55-60 °C for a minimum of 20 minutes (incubation time of Verify Assert SCBI as stated in K162701). Conclusion: PASS.
• Qualification testing with Verify Assert SCBI: 20-minute fluorescent read meets >97% alignment with 7-day growth results per FDA guidance on reduced incubation time. Conclusion: PASS.
• Qualification testing with Verify Assert SCBI: Pass testing with SCBI exposed to full cycle exposure and negative growth result in incubator. Fail testing with SCBI exposed in abbreviated cycle exposure and positive result in incubator. Conclusion: PASS.
• Alarm, LED and Print function Test: Demonstrate proper function of alarms, LED and print outputs. Conclusion: PASS.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K123546

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K163587

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is 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.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is 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.(2)
Classification. Class II (performance standards).

Summary

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Public Health Service

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

August 22, 2017

STERIS Corporation Anthony Piotrkowski Senior Regulatory Affairs Manager 5976 Heislev Rd Mentor, Ohio 44060

Re: K171587

Trade/Device Name: VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: July 31, 2017 Received: August 1, 2017

Dear Mr. 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

1

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.

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.

Tara A. Ryan -S

for

Lori Wiggins 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) K171587

Device Name

VERIFY Incubator for Assert VH2O2 Self Contained Biological Indicators

Indications for Use (Describe)

Use the VERIFY Incubator for Assert VH2O2 Self Contained Biological Indicators (Incubator) to incubate and automatically read VERIFY Assert VH2O2 Self-Contained Biological Indicators at 57 °C for 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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510(k) Summary For VERIFY® Incubator for Assert™ VH2O2 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: e-mail: [e-mail]

Submission Date: August 21, 2017

Premarket Notification Number: K171587

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™ VH2O2 Self
Contained Biological Indicators |
|------------------------|-----------------------------------------------------------------------------|
| Common/usual Name: | Incubator/Reader (accessory to Biological Indicator) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process
(21 CFR 880.2800, FRC) |

2. Predicate Device

3M Attest 390 Auto-reader, K123546

Reference Device: VERIFY® Incubator for Assert™ Self Contained Biological Indicators, K163587

3. Description of Device

VERIFY® Incubator for Assert™ | VH2O2 Self Contained Biological Indicators (Incubator) is an incubator/reader designed for use specifically with the VERIFY Assert |VH2O2| Self-Contained Biological Indicator (SCBI), subject of a concurrent submission, K171504, currently under review. The incubator/reader provides a constant temperature range to allow for activation and outgrowth of Geobacillus stearothermophilus leading to production of an endogenous 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 VH2O2 Self Contained Biological Indicators (Incubator) to incubate and automatically read VERIFY Assert VH2O2 Self-Contained Biological Indicators at 57 ℃ for a fluorescent result within 20 minutes.

5. Summary of Technical Characteristics

Comparisons of technical characteristics versus the predicate and reference devices are summarized in Tables 5-1 and 5-2 respectively.

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Table 5-1 Summary of Incubator Physical Description and Technological Properties vs Predicate

| Feature | VERIFY Incubator for
Assert VH2O2 SCBI
(proposed) | Attest 390
(K123546) Predicate | Comparison |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Use the VERIFY
Incubator for Assert
VH2O2 Self Contained
Biological Indicators to
incubate and automatically
read VERIFY Assert
VH2O2 Self-Contained
Biological Indicators at 57
°C for a fluorescent result
within 20 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 | 100-240 VAC with 12
VDC conversion. | 100-240 VAC with 12
VDC conversion. | Same |
| 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 | 20 minutes | 1 hour (1291), 3 hours
(1292) | Reduced incubation time
testing, in accordance with
FDA guidance, confirms
read time |
| Fluorescence
Detection | 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. | 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. | Same |
| Feature | VERIFY Incubator for
Assert VH2O2 SCBI
(proposed) | Attest 390
(K123546) Predicate | Comparison |
| System
Operation | The reader/incubator wells
are arranged in 2 banks of
4 wells and preset to 57℃.
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 yellow 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 one 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 VH2O2 SCBI
(proposed) | Attest 390
(K123546) Predicate | 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. |

6

7

8

Table 5-2 Summary of Incubator Physical Description and Technological Properties
vs Reference Device

| Feature | VERIFY Incubator for
Assert SCBI
(proposed) | VERIFY Incubator for
Assert SCBI K163587
(Reference) | Comparison |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Intended Use | Use the VERIFY
Incubator for Assert
VH2O2 Self Contained
Biological Indicators to
incubate and automatically
read VERIFY Assert
VH2O2 Self-Contained
Biological Indicators at 57 °C for a fluorescent result
within 20 minutes. | Use the VERIFY®
Incubator for Assert™
Self Contained Biological
Indicators SCBI to
incubate and automatically
read VERIFY Assert Self-
Contained Biological
Indicators at 57 °C for a
fluorescent result within
40 minutes. | 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 | 55 - 60 °C | Same |
| Voltage Range | 100-240 VAC with 12
VDC conversion. | 100-240 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 | 20 minutes | 40 minutes | Reduced incubation time
testing, in accordance with
FDA guidance, is confirms
read time. |
| Fluorescence
Detection | 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. | 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. | Same |

9

| K171587/S001 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION

VERIFY® Incubator for Assert™ VH2O2 Self-Contained Biological Indicators
	VERIFY Incubator for	VERIFY Incubator for
Feature	Assert SCBI	Assert SCBI K163587	Comparison
	(proposed)	(Reference)
C ----------	The vas device substances 11- The needer immer haten mis 11

| Feature | Assert SCBI
(proposed) | Assert SCBI K163587
(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 yellow 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 yellow 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 |

10

| Feature | VERIFY Incubator for
Assert SCBI
(proposed) | VERIFY Incubator for
Assert SCBI K163587
(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,
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 | 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 | Same |

Summary of Nonclinical Tests 6.

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-3 below.

Test	Acceptance Criteria	Conclusion
Maintenance of
Incubation
Temperature	Maintain 55-60 °C for a minimum of 20 minutes
(incubation time of Verify Assert SCBI as stated
in K162701)	PASS

Table 5-3. Summary of Non-clinical Testing

11

Test	Acceptance Criteria	Conclusion
Qualification testing
with Verify Assert
SCBI	20-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
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 VH2O2 Assert Self-Contained Biological Indicator has met the established performance criteria. Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as the legally marketed predicate device, K123546, Class II (21 CFR 880.2800, Product code FRC).