(96 days)
No
The device description and intended use focus on physical and chemical indicators for sterilization, with no mention of AI or ML.
No
This device is designed to test the air removal efficiency of pre-vacuum steam sterilizers and monitor steam sterilization cycles, not to treat any medical condition or disease in a patient.
No
The device is designed to test the efficacy of sterilizers, specifically the air removal efficiency and steam penetration, by monitoring sterilization conditions. It does not diagnose a medical condition in a patient.
No
The device description clearly outlines physical components like a reusable aluminum tube, a tortuous path challenge, and disposable polypropylene sleeves. It also relies on external hardware like biological indicators, chemical integrators, and an incubator. This is not a software-only device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this device is used to test the air removal efficiency and challenge the steam sterilization process of sterilizers, not to analyze human specimens.
- The device monitors the sterilization process itself. It uses indicators (Bowie Dick, biological, and integrating) to assess whether the sterilizer is functioning correctly to achieve sterilization conditions. This is a quality control measure for the sterilization equipment, not a diagnostic test performed on a patient sample.
The device falls under the category of sterilization process indicators or sterilization monitoring devices, which are distinct from IVDs.
N/A
Intended Use / Indications for Use
The VERIFY All-In-One STEAM Reusable Test Pack, when used with a VERIFY Bowie Dick Indicator Strip, is designed for testing the air removal efficiency of prevacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1°C/-0°C) temperature difference between the center of the ANSI/AAMI/ISO 1140-5:2007 Standard Test Pack and the drain temperature at the beginning of the final minute of a three and a half minute cycle, the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window). The test parameters used for validating this device for 134°C for 3.5 minutes with a 2 minute dry time.
VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization cycles utilizing a biological indicator, integrating indicator or both a biological and integrating indicator from the following list.
- 3M ATTEST Rapid Read Biological Indicators catalog number 1292 manufactured by 3M Company
- 3M ATTEST Super Rapid Read Biological Indicators catalog number 1492V manufactured by 3M Company
- Smart-Read EZTest Self Contained Biological Indicators for steam manufactured by MesaLabs, Inc.
- Celerity 20 Steam Biological Indicator
- VERIFY |STEAM | Integrating Indicator
VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge the steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization cycles with the VERIFY |STEAM Integrating Indicator.
The VERIFY All-In-One STEAM Reusable Test Pack employing the All-in-One PV10 Assembly (a disposable polypropylene sleeve assembly) with a 3M ATTEST Rapid Readout Biological Indicator catalog number 1292 can be used for routine monitoring of 10-Minute 270°F/132°C pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Reusable Test Pack.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The VERIFY All-in-One STEAM Reusable Test Pack (formerly identified as the Dana Reusable Test Pack) consists of a reusable aluminum tube with a tortuous path challenge for air removal and steam penetration. The VERIFY All-in-One STEAM Reusable Test Pack will be used with the Celerity 20 Steam Biological Indicator (subject of a separate, concurrent 510(k) premarket notification) with or without the VERIFY STEAM Integrating Integrator (cleared under K152630).
The Celerity 20 Steam Biological Indicator monitors the critical parameters of steam sterilization cycles by producing an optical change (signal) that is detected by the STERIS proprietary reader, Celerity Steam Incubator in 20 minutes to confirm viability of the biological indicator at the end of a steam sterilization process. Both the Celerity 20 Steam Biological Indicator and Incubator are subjects of separate 510(k) premarket notifications.
The VERIFY STEAM Integrating Integrator (cleared in K152630) is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY |STEAM Integrating Integrator may be included in the pack and processed according to the pack's instructions for use.
The user will place the assembled VERIFY All-in-One STEAM Reusable Test Pack containing the Celerity 20 Steam Biological Indicator with or without the VERIFY STEAM Integrating Integrator into the sterilizer chamber and perform a 4-minute 270°F pre-vacuum steam sterilization cycle.
At the end of the cycle, the user will remove the Celerity 20 Steam Biological Indicator and the VERIFY |STEAM Integrating Integrator from the pack. The Celerity 20 Steam Biological Indicator can either be immediately activated or held at room temperature for a maximum of 72 hours (3 days) prior to activation by twisting the cap and thus puncturing the cap to release the contained media. The activated BI is incubated at 55-60°C in the Celerity Steam Incubator for a final determination of viability within 20 minutes of incubation.
The VERIFY |STEAM Integrating Integrator will be evaluated for a passing or failing result by observing the dark bar of the device. If the dark bar enters the ACCEPT (OK) window, the integrator is read as a PASS. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL.
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
healthcare facilities.
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)
Study Type: Nonclinical Tests
Sample Size: Not specified
Key Results:
The "Summary of Nonclinical Tests" table indicates the following:
- Simulated Use:
- Performance of the BI in the Reusable Test Pack is equivalent to the performance of the BI in the AAMI 16 towel test pack. Conclusion: PASS
- Performance of the chemical integrator in the Reusable Test Pack is equivalent to the performance of the chemical integrator in the AAMI 16 towel test pack. Conclusion: PASS
- Reusable Test Pack provides an equivalent or greater challenge than the AAMI 16 towel test pack. Conclusion: PASS
- BI in pack vs BI outside of pack:
- Reusable Test Pack provides a greater challenge to the process than the BI itself. Conclusion: PASS
- CI in pack vs CI outside of pack:
- Reusable Test Pack provides a greater challenge to the process than the integrator by itself. 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.
K133267 Dana Reusable Test Pack
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.
K152630, K120592, K092944, K130135, K102761, K103321
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
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 28, 2018
STERIS Corporation Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Rd Mentor, Ohio 44060
Re: K173633
Trade/Device Name: VERIFY™ All-in-One STEAM Reusable Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: January 26, 2018 Received: January 29, 2018
Dear Jennifer Nalepka:
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 of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set 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.
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.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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) K173633
Device Name
VERIFY All-In-One STEAM Reusable Test Pack
Indications for Use (Describe)
The VERIFY All-In-One STEAM Reusable Test Pack, when used with a VERIFY Bowie Dick Indicator Strip, is desing the air removal efficiency of pre-vacuum sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1° C/-0°C) temperature difference between the center of the ANSI/AAMI/ISO 11140-52007 Standard Test Pack and the drain temperature at the beginning of the final minute cycle. the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window). The test parameters used for 134°C for 3.5 minutes with a 2 minute dry time.
VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132° C pre-vacuum steam sterlization cycles utilizing a biological indicator or both a biological and integrating indicator from the following list.
- 3M ATTEST Rapid Read Biological Indicators catalog number 1292 manufactured by 3M Company
- . 3M ATTEST Super Rapid Read Biological Indicators catalog number 1492V manufactured by 3M Company
- Smart-Read EZTest Self Contained Biological Indicators for steam manufactured by MesaLabs, Inc.
- . Celerity 20 Steam Biological Indicator
- . VERIFY STEAM Integrating Indicator
VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge the steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterlization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization cycles with the VERIFY STEAM Integrating Indicator.
The VERIFY All-In-One STEAM Resuable Test Pack employing the All-in-One PV10 Assembly (a disposable polypropylene sleeve assembly) with a 3M ATTEST Rapid Biological Indicator catalog number 1292 can be used for routine monitoring of 10-Minute 270°F/132°C pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Resuable Test Pack.
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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3
STERIS®
510(k) Summary For VERIFY™ All-in-One STEAM Reusable Test Pack
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Manufacturing Facility
STERIS Corporation Franklin Park Facility 11457 Melrose Ave. Franklin Park, IL 60131 Phone: (847) 455-2881
Jennifer Nalepka Contact: Senior Regulatory Affairs Specialist
Telephone: (440) 392-7458 Fax No: (440) 357-9189 e-mail: jennifer_nalepka@steris.com
February 21, 2018 Submission Date:
Premarket Notification Number: K173633
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
1. Device Name
| Trade Name: | VERIFY™ All-in-One STEAM Reusable Test Pack |
|---|---|
| Common/usual Name: | Biological Indicator Challenge Pack |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process |
| (21 CFR 880.2800, FRC) |
2. Predicate Device
K133267 Dana Reusable Test Pack
Description of Device 3.
The VERIFY All-in-One STEAM Reusable Test Pack (formerly identified as the Dana Reusable Test Pack) consists of a reusable aluminum tube with a tortuous path challenge for air removal and steam penetration. The VERIFY All-in-One STEAM Reusable Test Pack will be used with the Celerity 20 Steam Biological Indicator (subject of a separate, concurrent 510(k) premarket notification) with or without the VERIFY STEAM Integrating Integrator (cleared under K152630).
The Celerity 20 Steam Biological Indicator monitors the critical parameters of steam sterilization cycles by producing an optical change (signal) that is detected by the STERIS proprietary reader, Celerity Steam Incubator in 20 minutes to confirm viability of the biological indicator at the end of a steam sterilization process. Both the Celerity 20 Steam Biological Indicator and Incubator are subjects of separate 510(k) premarket notifications.
The VERIFY STEAM Integrating Integrator (cleared in K152630) is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY |STEAM Integrating Integrator may be included in the pack and processed according to the pack's instructions for use.
The user will place the assembled VERIFY All-in-One STEAM Reusable Test Pack containing the Celerity 20 Steam Biological Indicator with or without the VERIFY STEAM Integrating Integrator into the sterilizer chamber and perform a 4-minute 270°F pre-vacuum steam sterilization cycle.
At the end of the cycle, the user will remove the Celerity 20 Steam Biological Indicator and the VERIFY |STEAM Integrating Integrator from the pack. The Celerity 20 Steam Biological Indicator can either be immediately activated or held at room temperature for a maximum of 72 hours (3 days) prior to activation by twisting the cap and thus puncturing the cap to release the contained media. The
5
activated BI is incubated at 55-60°C in the Celerity Steam Incubator for a final determination of viability within 20 minutes of incubation.
The VERIFY |STEAM Integrating Integrator will be evaluated for a passing or failing result by observing the dark bar of the device. If the dark bar enters the ACCEPT (OK) window, the integrator is read as a PASS. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL.
4. Intended Use/ Indications for Use
The VERIFY All-In-One STEAM Reusable Test Pack, when used with a VERIFY Bowie Dick Indicator Strip, is designed for testing the air removal efficiency of prevacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1°C/-0°C) temperature difference between the center of the ANSI/AAMI/ISO 1140-5:2007 Standard Test Pack and the drain temperature at the beginning of the final minute of a three and a half minute cycle, the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window). The test parameters used for validating this device for 134°C for 3.5 minutes with a 2 minute dry time.
VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4minute 270°F/132°C pre-vacuum steam sterilization cycles utilizing a biological indicator, integrating indicator or both a biological and integrating indicator from the following list.
- . 3M ATTEST Rapid Read Biological Indicators catalog number 1292 manufactured by 3M Company
- 3M ATTEST Super Rapid Read Biological Indicators catalog number ● 1492V manufactured by 3M Company
- Smart-Read EZTest Self Contained Biological Indicators for steam manufactured by MesaLabs, Inc.
- Celerity 20 Steam Biological Indicator
- VERIFY |STEAM | Integrating Indicator
VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge the steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization cycles with the VERIFY |STEAM Integrating Indicator.
The VERIFY All-In-One STEAM Reusable Test Pack employing the All-in-One PV10 Assembly (a disposable polypropylene sleeve assembly) with a 3M ATTEST Rapid Readout Biological Indicator catalog number 1292 can be used for routine
6
monitoring of 10-Minute 270°F/132°C pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Reusable Test Pack.
5. Summary of Technical Characteristics
A comparison of technical characteristics are summarized in Table 5-1.
| Feature | VERIFY All-In-One
STEAM Reusable Test
Pack
(K173633) | Dana Reusable Test
Pack
(K133267) | Comparison |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indication for
Use | The VERIFY All-In-One
STEAM Reusable Test
Pack, when used with a
VERIFY Bowie Dick
Indicator Strip, is designed
for testing the air removal
efficiency of pre-vacuum
steam sterilizers. The
indicator will demonstrate
complete dye migration
when proper sterilization
conditions are met and
proper vacuum is
achieved. If there is
inadequate vacuum such
that would result in a 2°C
(+1°C/-0°C) temperature
difference between the
center of the
ANSI/AAMI/ISO 1140-
5:2007 Standard Test Pack
and the drain temperature
at the beginning of the
final minute of a three and
a half minute cycle, the
indicator will demonstrate
incomplete dye migration
(incomplete color change
in the indicator window).
The test parameters used
for validating this device
for 134°C for 3.5 minutes
with a 2 minute dry time.
VERIFY All-In-One
STEAM Reusable Test
Pack is designed to
challenge steam
sterilization process in | The Dana Reusable Test
Pack is designed to
challenge steam
sterilization process in
healthcare facilities. It is
intended to be used for
routine monitoring of pre-
vacuum steam sterilization
cycles. It is validated to be
used in 4 minute 270°F
pre-vacuum steam
sterilization cycles with a
3M Attest Super Rapid
Readout Biological
Indicator 1492V along
with or without SteriScan
Integrators. | The proposed and predicate
devices are identical. The
current premarket
notification is to add the use
of the Celerity 20 Steam
Biological Indicator
(submitted in a separate,
concurrent premarket
notification) in the VERIFY
All-In-One STEAM
Reusable Test Pack.
The following claims for use
of the VERIFY All-In-One
Reusable Test Pack have
been previously cleared:
Bowie Dick Indicator when
used with the VERIFY
Bowie Dick Indicator Strip
(K120592)
Routine Monitoring of a 4-
minute 270°F/132°C pre-
vacuum steam sterilization
cycle when used with:
• 3M ATTEST Rapid Readout
Biological Indicators
catalog number 1292
manufactured by 3M
Company (K092944)
• Smart-Read EZTest Self
Contained Biological
Indicators for steam
manufactured by
MesaLabs, Inc.
(K130135) |
| Feature | VERIFY All-In-One
STEAM Reusable Test
Pack
(K173633) | Dana Reusable Test
Pack
(K133267) | Comparison |
| | healthcare facilities. It is
intended to be used for
routine monitoring of pre-
vacuum steam sterilization
cycles. It is validated to
be used in 4-minute
270°F/132°C pre-vacuum
steam sterilization cycles
utilizing a biological
indicator, integrating
indicator or both a
biological and integrating
indicator from the
following list.
3M ATTEST Rapid
Read Biological
Indicators catalog
number 1292
manufactured by 3M
Company 3M ATTEST Super
Rapid Read Biological
Indicators catalog
number 1492V
manufactured by 3M
Company Smart-Read EZTest
Self Contained
Biological Indicators
for steam manufactured
by MesaLabs, Inc. Celerity 20 Steam
Biological Indicator VERIFY STEAM
Integrating Indicator | | VERIFY STEAM
Integrating Indicator
(K102761) Routine Monitoring of a 10-
minute 270°F/132°C pre-
vacuum steam sterilization
cycle when used with the
additional polypropylene
sleeve assembly and the 3M
ATTEST Rapid Readout
Biological Indicator catalog
number 1292 (K103321)
NOTE: In previous
submissions, the VERIFY
All-In-One STEAM
Reusable Pack was referred
to as the Dana Reusable Test
Pack and the VERIFY
STEAM Integrating
Integrator was called the
SteriScan Integrator. |
| | VERIFY All-In-One
STEAM Reusable Test
Pack is designed to
challenge the steam
sterilization process in
healthcare facilities. It is
intended to be used for
routine monitoring of pre-
vacuum steam sterilization
cycles. It is validated to
be used in 4-minute
270°F/132°C pre-vacuum
steam sterilization cycles | | |
| Feature | VERIFY All-In-One
STEAM Reusable Test
Pack
(K173633) | Dana Reusable Test
Pack
(K133267) | Comparison |
| | STEAM Integrating
Indicator.
The VERIFY All-In-One
STEAM Reusable Test
Pack employing the All-
in-One PV10 Assembly (a
disposable polypropylene
sleeve assembly) with a
3M ATTEST Rapid
Readout Biological
Indicator catalog number
1292 can be used for
routine monitoring of 10-
Minute 270°F/132°C pre-
vacuum steam sterilization
cycles. The polypropylene
sleeve assembly is
intended to be used only
with the VERIFY All-In-
One STEAM Reusable
Test Pack. | | |
| General
Design | Aluminum chamber that
can be sealed at one end
using a removable
aluminum plug. The other
end has a permanently
pressed in aluminum cap
with a precision machined
spiral that provides a
tortuous path for air
removal. The aluminum
chamber is large enough to
contain a biological
indicator and chemical
indicator. | Aluminum chamber that
can be sealed at one end
using a removable
aluminum plug. The other
end has a permanently
pressed in aluminum cap
with a precision machined
spiral that provides a
tortuous path for air
removal. The aluminum
chamber is large enough to
contain a biological
indicator and chemical
indicator. | Identical configuration |
Table 5-1 Summary of pack Physical Description and Technological Properties
7
8
9
| Feature | VERIFY All-In-One
STEAM Reusable Test
Pack
(K173633) | Dana Reusable Test
Pack
(K133267) | Comparison |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biological
Indicator | 3M ATTEST Rapid Read Biological
Indicators catalog number 1292
manufactured by 3M Company 3M ATTEST Super Rapid Read Biological
Indicators catalog number 1492V
manufactured by 3M Company Smart-Read EZTest Self Contained
Biological Indicators for steam manufactured
by MesaLabs, Inc. Celerity 20 Steam Biological Indicator | 3M ATTEST Super Rapid
Read Biological Indicators
catalog number 1492V
manufactured by 3M
Company | The proposed and predicate
devices are identical. The
current premarket
notification is to add the use
of the Celerity 20 Steam
Biological Indicator
(submitted in a separate,
concurrent premarket
notification) in the VERIFY
All-In-One STEAM
Reusable Test Pack.
The following BIs were
cleared in previous
submissions: 3M ATTEST Rapid Read
Biological Indicators
catalog number 1292
manufactured by 3M
Company (K092944) Smart-Read EZTest Self
Contained Biological
Indicators for steam
manufactured by
MesaLabs, Inc.
(K130135) |
| Chemical
Indicator | VERIFY STEAM
Integrating Indicator | VERIFY STEAM
Integrating Indicator
(previously branded as the
Steriscan Integrating
Integrator) | Same |
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 |
|---|---|---|
| Simulated Use | Performance of the BI in the Reusable Test Pack is | |
| equivalent to the performance of the BI in the AAMI 16 | ||
| towel test pack. | PASS | |
| Performance of the chemical integrator in the Reusable | ||
| Test Pack is equivalent to the performance of the chemical | ||
| integrator in the AAMI 16 towel test pack. | PASS | |
| Reusable Test Pack provides an equivalent or greater | ||
| challenge than the AAMI 16 towel test pack. | PASS | |
| BI in pack vs BI outside | ||
| of pack | Reusable Test Pack provides a greater challenge to the | |
| process than the BI itself. | PASS |
Table 5-2. Summary of Non-clinical Testing
10
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| CI in pack vs CI outside of pack | Reusable Test Pack provides a greater challenge to the process than the integrator by itself. | PASS |
7. Conclusion
The VERIFY All-in-One STEAM Reusable Test Pack has met the established performance criteria. Based on the conclusions drawn from the intended use, technological characteristics and nonclinical tests demonstrate that the subject device is as safe, as effective, and performs at least as well as the legally marketed predicate device, Dana Reusable Test Pack cleared in K133267 Class II (21 CFR 880.2800, Product code FRC).