(175 days)
No
The description focuses on the chemical sterilization process, water filtration, and automated control of the system. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is a liquid chemical sterilization system used to sterilize medical devices, not for therapeutic purposes on patients.
No
This device is a sterilization system used to sterilize medical devices, not to diagnose medical conditions in patients.
No
The device description clearly outlines a physical system including a processor, sterilant concentrate, processing trays, and quick connects, indicating it is a hardware-based medical device with integrated software for control and monitoring.
Based on the provided text, the device described is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the liquid chemical sterilization of medical devices (critical and semi-critical) used in healthcare facilities. This is a process applied to medical instruments, not a test performed on biological samples to diagnose a condition.
- Device Description: The device is a processing system that uses a chemical sterilant and treated water to sterilize medical devices. It does not involve the analysis of biological specimens.
- Performance Studies: The performance studies focus on the efficacy of the sterilization process (microbial efficacy) and the compatibility of the system with medical devices (biocompatibility). These are not the types of studies typically associated with IVDs, which would focus on analytical performance (sensitivity, specificity, etc.) related to detecting substances or characteristics in biological samples.
In summary, the SYSTEM 1E Liquid Chemical Sterilant Processing System is a medical device used for reprocessing other medical devices, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities. The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use.
The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
- The extensive treatment of EPA potable water consists of:
- Pre-filtration through two pre-filters:
- Pre-filter A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants.
- Pre-filter B is a surface filter that removes particles/contaminants > 0.1 micron.
- UV Irradiation:
- During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
- 0.1 micron filtration:
- The water prepared by pre-filtration and UV irradiation is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.
Product codes
MED
Device Description
The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects.
The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment subsystem, and then through two 0.1 micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.
S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed exclusively for use in the SYSTEM 1E Processor. The active ingredient in S40 Sterilant Concentrate, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.
The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects for the SYSTEM 1E Processor, if required, facilitate delivery of the liquid chemical sterilant use dilution and rinse water to internal channels.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6885 Liquid chemical sterilants/high level disinfectants.
(a)
Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.(b)
Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and are arranged in a way that suggests movement or flow. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 22, 2017
Steris Corporation Tricia Cregger Senior Manager, Regulatory Affairs 5960 Heisley Rd Mentor. Ohio 44060
Re: K170956
Trade/Device Name: System 1E Liquid Chemical Sterilant Processing System Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: Class II Product Code: MED Dated: August 25, 2017 Received: August 28, 2017
Dear Tricia Cregger:
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
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely, Tara A. Ryan -S 2017.09.22 19:20:55 -04'00'
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) K170956
Device Name
SYSTEM 1E Liquid Chemical Sterilant Processing System
Indications for Use (Describe)
The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities. The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use.
The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liguid chemically sterilize medical devices.
- The extensive treatment of EPA potable water consists of:
- Pre-filtration through two pre-filters:
- · Pre-filter A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants.
- · Pre-filter B is a surface filter that removes particles/contaminants > 0.1 micron.
2. UV Irradiation:
- During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
3.0.1 micron filtration:
· The water prepared by pre-filtration and UV irradiation is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for STERIS. The word "STERIS" is written in a serif font in all capital letters. Below the word is a graphic of several horizontal wavy lines in blue. The registered trademark symbol is to the right of the word STERIS.
510(k) Summary For SYSTEM 1E Liquid Chemical Sterilant Processing System
STERIS Corporation 5960 Heisley Road Mentor, OH 44060
Tricia Cregger, Ph. D. Contact: Senior Manager, Regulatory Affairs Tel: 440-392-7189 Fax: 440-357-9198
September 22, 2017 Summary Date:
Premarket Notification Number: K170956
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
1. Device Name
| Trade Name: | SYSTEM 1E Liquid Chemical Sterilant
Processing System |
|------------------------|-------------------------------------------------------------------------|
| Device Classification: | Class II |
| Common/usual Name: | Liquid Chemical Sterilizer |
| Classification Name: | Sterilant, Medical devices, Liquid Chemical
Sterilants/Disinfectants |
| Classification Number: | 21 CFR 880.6885 |
| Product Code: | MED |
2. Predicate Device
SYSTEM 1E Liquid Chemical Sterilant Processing System cleared under K161683
3. Description of Device
The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects. The device was originally cleared under K090036. Five Special 510(k)s were cleared that subsequently made minor modifications to hardware, software, specifications, and labeling. This premarket notification introduces a new processing tray that will accommodate ultrasound endoscopes and other large flexible devices and their associated Quick Connects. Additionally, minor inconsistent statements in the cleared Indications for Use are corrected, and clarification is provided on post-processing handling and storage of critical and semi-critical medical devices.
The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment subsystem, and then through two 0.1 micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.
5
S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed exclusively for use in the SYSTEM 1E Processor. The active ingredient in S40 Sterilant Concentrate, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.
The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects for the SYSTEM 1E Processor, if required, facilitate delivery of the liquid chemical sterilant use dilution and rinse water to internal channels.
4. Intended Use
The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semicritical heat-sensitive medical devices in healthcare facilities.
The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use.
The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
- 米 The extensive treatment of EPA potable water consists of:
-
- Pre-filtration through two pre-filters:
- Pre-filter A is a gross depth filter that removes approximately 2.5 . micron or larger particles/contaminants.
- Pre-filter B is a surface filter that removes particles/contaminants > . 0.1 micron.
-
- UV Irradiation:
- During transit through the UV water treatment chamber, a UV dose . sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
-
- 0.1 micron filtration:
- The water prepared by pre-filtration and UV irradiation is filtered ● through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.
-
6
ડ. Description of Technological Similarities and Differences
The SYSTEM 1E Liquid Chemical Sterilant Processing System is the same as the predicate device except for the specific modification described in this submission. The differences between the proposed and predicate devices are limited to the addition of a new Ultrasound Processing Tray and the Quick Connects that enable the processing of large flexible ultrasound devices and labeling updates to correct errors and provide clarity to users and these proposed changes raise no new concerns of safety and effectiveness when compared to the predicate device.
| Feature | Proposed
SYSTEM 1E Processor | K161683
SYSTEM 1E Processor | Comparison |
|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The SYSTEM 1E Liquid
Chemical Sterilant Processing
System is intended for liquid
chemical sterilization of
cleaned, immersible, and
reusable critical and semi-critical heat-sensitive medical
devices in healthcare facilities. | The SYSTEM 1E Liquid
Chemical Sterilant Processing
System is intended for liquid
chemical sterilization of
cleaned, immersible, and
reusable critical and semi-critical heat-sensitive medical
devices in healthcare facilities. | The minor
differences
between the
Indications for
Use for the
proposed and
predicate devices
are for the
correction of
errors in the
Indications for
Use, for changes
in designation of
the pre-filters
from 1 and 2 to A
and B for
consistency with
all other labeling
and to provide
clarity for usage
and storage of
processed
devices. There
were no changes
in performance. |
| | The SYSTEM 1E Processor
dilutes the S40 Sterilant
Concentrate to its use dilution
(>1820 mg/L peracetic acid),
liquid chemically sterilizes the
load during a controlled 6-
minute exposure at 45.5 to
60℃, and rinses the load with
extensively treated* potable
water. After completion of a
cycle, critical devices should
be used immediately; semi-
critical devices should be used
immediately or may be
handled and stored in a
manner similar to that of high
level disinfected endoscopes.
Critical devices not used
immediately should be
processed again before use. | The SYSTEM 1E Processor
dilutes the S40 Sterilant
Concentrate to its use dilution
(>1820 mg/L peracetic acid),
liquid chemically sterilizes the
load during a controlled 6-
minute exposure at 46 to
55℃, and rinses the load with
extensively treated* potable
water. The processed load
should be used immediately.
The SYSTEM 1E Processor
uses only S40 Sterilant
Concentrate to liquid
chemically sterilize medical
devices.
- The extensive treatment of
EPA potable water consists of:
- Pre-filtration through two | |
| | Proposed | K161683 | |
| Feature | SYSTEM 1E Processor | SYSTEM 1E Processor | Comparison |
| | The SYSTEM 1E Processor
uses only S40 Sterilant
Concentrate to liquid
chemically sterilize medical
devices.
- The extensive treatment of
EPA potable water consists of:
- Pre-filtration through two
pre-filters:
• Pre-filter A is a gross
depth filter that
removes approximately
2.5 micron or larger
particles/contaminants.
• Pre-filter B is a surface
filter that removes
particles/contaminants
0.1 micron.
- UV Irradiation:
• During transit through
the UV water treatment
chamber, a UV dose
sufficient to achieve a
$\ge$ 6-log reduction of
MS2 virus is delivered
to the water. - 0.1 micron filtration:
• The water prepared by
pre-filtration and UV
irradiation is filtered
through redundant, 0.1-
micron (absolute rated)
membranes to remove
bacteria, fungi and
protozoa > 0.1 micron. | pre-filters:
• Pre-filter 1 is a gross
depth filter that
removes approximately
5 micron or larger
particles/contaminants.
• Pre-filter 2 is a surface
filter that removes
particles/contaminants
0.1 micron.
- UV Irradiation:
• During transit through
the UV water treatment
chamber, a UV dose
sufficient to achieve a
$\ge$ 6-log reduction of
MS2 virus is delivered
to the water. - 0.1 micron filtration:
• The water prepared by
pre-filtration and UV
irradiation is filtered
through redundant, 0.1-
micron (absolute rated)
membranes to remove
bacteria, fungi and
protozoa > 0.1 micron. | |
| Feature | Proposed
SYSTEM 1E Processor | K161683
SYSTEM 1E Processor | Comparison |
| Operating
Principles/
Technology | A microprocessor controlled
unit with interchangeable
processing trays/containers.
The processor lid opens to
reveal the processing chamber
in which the load is placed.
Devices with internal lumens
are interfaced with the
processor using connectors.
Sterilant Concentrate is placed
in a specialized compartment
and when the processor fills
with water, it creates the
sterilant use dilution from the
single use sterilant cup. The
processor monitors and
controls the use dilution
temperature and contact time.
The processor automatically
rinses the load with
extensively treated water to
remove sterilant residuals. | A microprocessor controlled
unit with interchangeable
processing trays/containers.
The processor lid opens to
reveal the processing chamber
in which the load is placed.
Devices with internal lumens
are interfaced with the
processor using connectors.
Sterilant Concentrate is placed
in a specialized compartment
and when the processor fills
with water, it creates the
sterilant use dilution from the
single use sterilant cup. The
processor monitors and
controls the use dilution
temperature and contact time.
The processor automatically
rinses the load with
extensively treated water to
remove sterilant residuals. | Identical |
| Process
Parameters | Standardized cycle parameters
cannot be altered by operator.
The critical process
parameters are:
Contact Time Use Dilution Temperature Peracetic acid
concentration Bacterial retentive water
filter integrity UV irradiation | Standardized cycle parameters
cannot be altered by operator.
The critical process
parameters are:
Contact Time Use Dilution Temperature Peracetic acid
concentration Bacterial retentive water
filter integrity UV irradiation | Identical |
| Process
Monitors | Cycle Printout documents
successful cycle
completion or identifies
fault if cycle aborts Alarms if thermocouples
indicate temperature out
of specification Alarms if pressure switch
indicates that high
pressure pump is not
operating | Cycle Printout documents
successful cycle
completion or identifies
fault if cycle aborts Alarms if thermocouples
indicate temperature out
of specification Alarms if pressure switch
indicates that high
pressure pump is not
operating | Identical |
| | Proposed | K161683 | |
| Feature | SYSTEM 1E Processor | SYSTEM 1E Processor | Comparison |
| Design
Features | probe indicated
conductivity specification
not met Alarms if pressure
transducer indicates
circulation pressure is out
of specification during
Diagnostic cycle Alarms if pressure
transducer indicates 0.1
micron water filter failed
integrity test during
liquid chemical sterilant
processing and
Diagnostic cycles. Alarms if UV monitor
indicates UV intensity
out of specification Microprocessor
controlled unalterable
and standardized liquid
chemical sterilant
processing and
Diagnostic cycles Intended for use with S40
Sterilant Concentrate Processor provides dual
0.1 micron filtered, UV
treated water for liquid
chemical sterilant
processing and rinsing Automated dilution and
delivery of sterilant Make up air for processor
during drain sequences is
filtered through a 0.2
micron membrane air
filter. | probe indicated
conductivity specification
not met Alarms if pressure
transducer indicates
circulation pressure is out
of specification during
Diagnostic cycle Alarms if pressure
transducer indicates 0.1
micron water filter failed
integrity test during
liquid chemical sterilant
processing and
Diagnostic cycles. Alarms if UV monitor
indicates UV intensity
out of specification Microprocessor
controlled unalterable
and standardized liquid
chemical sterilant
processing and
Diagnostic cycles Intended for use with S40
Sterilant Concentrate Processor provides dual
0.1 micron filtered, UV
treated water for liquid
chemical sterilant
processing and rinsing Automated dilution and
delivery of sterilant Make up air for processor
during drain sequences is
filtered through a 0.2
micron membrane air
filter. | Identical |
| Processing Cycle | | | |
| Incoming
water
temperature | $ \u2265 43°C $ | $ \u2265 43°C $ | Identical |
| Temperature
to start
exposure
phase | $ \u2265 46°C $ | $ \u2265 46°C $ | Identical |
| Feature | Proposed
SYSTEM 1E Processor | K161683
SYSTEM 1E Processor | Comparison |
| Temperature
alarm point
during the
exposure
phase | 60°C | 60°C | Identical |
| Temperature
range during
a typical
Liquid
Chemical
Sterilant
Processing
Cycle | 46 - 55°C | 46 - 55°C | Identical |
| Exposure
Time | 6 minutes | 6 minutes | Identical |
| Rinse water
preparation | Hot potable tap water is:
• pre-filtered
• flowed through a UV
Light treatment chamber
to achieve ≥ a 6-log
reduction of virus
• Filtered through
redundant 0.1 micron
filter membranes | Hot potable tap water is:
• pre-filtered
• flowed through a UV
Light treatment chamber
to achieve ≥ a 6-log
reduction of virus
• Filtered through
redundant 0.1 micron
filter membranes | Identical |
| Number of
rinses | 2 | 2 | Identical |
| Air Purge | Aids in removing excess water
from instrument lumens after
rinsing | Aids in removing excess water
from instrument lumens after
rinsing | Identical |
| Water Filter
Integrity
Test | Conducted at the end of every
liquid chemical sterilant
processing cycle and during
the Diagnostic cycle | Conducted at the end of every
liquid chemical sterilant
processing cycle and during
the Diagnostic cycle | Identical |
| Approximate
Cycle time | 25 minutes | 25 minutes | Identical |
| Feature | Proposed
SYSTEM 1E Processor | K161683
SYSTEM 1E Processor | Comparison |
| Diagnostic
Cycle | Performs 15 tests on processor's systems confirming proper function (same tests as predicate device except for an added UV monitor test). Recommended to perform every 24 hours. After a failed Diagnostic cycle, a liquid chemical sterilant processing cycle cannot be performed until the problem is rectified and a successful Diagnostic cycle has been completed. | Performs 15 tests on processor's systems confirming proper function (same tests as predicate device except for an added UV monitor test). Recommended to perform every 24 hours. After a failed Diagnostic cycle, a liquid chemical sterilant processing cycle cannot be performed until the problem is rectified and a successful Diagnostic cycle has been completed. | Identical |
| Interchangeable Components | | | |
| Processing Tray / Containers | Uses interchangeable processing trays/containers Universal Flexible Processing Tray (C1160E) General Processing Container/Tray (C1200) Directed Flow Processing Container/Tray (C1220) Flexible Endoscope Processing Container / Tray (C1140) Ultrasound Processing Tray (C3000XL) | Uses interchangeable processing trays/containers Universal Flexible Processing Tray (C1160E) General Processing Container/Tray (C1200) Directed Flow Processing Container/Tray (C1220) Flexible Endoscope Processing Container / Tray (C1140) | The proposed device has available one more interchangeable tray than does the predicate device. This additional tray is designed for processing large ultrasound devices that do not fit into the other trays. Any new safety and efficacy concerns were addressed through verification testing. |
| Accessories | | | |
| Sterilant Concentrate | Uses S40 Sterilant Concentrate | Uses S40 Sterilant Concentrate | Identical |
| Quick Connects | Uses Quick Connects to adapt instrument lumens to the Tray/Container ports | Uses Quick Connects to adapt instrument lumens to the Tray/Container ports | The proposed device has additional Quick Connects to enable the processing of the larger ultrasound devices in the Ultrasound |
| Feature | Proposed
SYSTEM 1E Processor | K161683
SYSTEM 1E Processor | Comparison |
| | | | Processing Tray.
These Quick
Connects
function in a
similar manner to
currently
marketed Quick
Connects. Any
new safety and
efficacy concerns
were addressed
through
verification
testing. |
| Chemical
Indicator | VERIFY Chemical Indicator
for the SYSTEM 1E Processor
(K102217) | VERIFY Chemical Indicator
for the SYSTEM 1E
Processor (K102217) | Identical |
| Spore Test
Strip | VERIFY Spore Test Strip for
S40 Sterilant Concentrate
(K100049) | VERIFY Spore Test Strip for
S40 Sterilant Concentrate
(K100049) | Identical |
| Operator
Maintenance
Requirements | Periodic replacement of
printer tape, water filters and
air filter | Periodic replacement of
printer tape, water filters and
air filter | Identical |
Device Comparison Table
Table 5-1. Processor Device Comparison Table
7
8
9
10
11
12
Table 5-2. Sterilant Concentrate Device Comparison Table
| Feature | Proposed
S40 Sterilant Concentrate | K161683
S40 Sterilant Concentrate | Comparison |
|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for
Use | S40 Sterilant Concentrate is
for use only with the
SYSTEM 1E Liquid
Chemical Sterilant
Processing System | S40 Sterilant Concentrate is
for use only with the
SYSTEM 1E Liquid
Chemical Sterilant
Processing System | Identical |
| Germicidal
claim | Liquid Chemical Sterilant | Liquid Chemical Sterilant | Identical |
| Germicide
Exposure Time
(min) for
intended use | 6 | 6 | Identical |
| Use
Temperature | 45.5-60°C -- allowable
46-55°C - typical
Potency and simulated use
evaluations conducted at
6 log10 reduction
Geobacillus
stearothermophilus spores
in a manual application | Meets efficacy requirement.
6 log10 reduction
Geobacillus
stearothermophilus spores
in a manual application | Identical |
| Clinical In-Use | No surviving
microorganisms on
representative medical
devices tested | No surviving
microorganisms on
representative medical
devices tested | Identical |
| Biocompatibility | | | |
| Cytotoxicity
Device Extracts | Two rinses with UV treated,
dual 0.1 micron membrane
filtered water effectively
reduce sterilant residues to
safe levels. | Two rinses with UV treated,
dual 0.1 micron membrane
filtered water effectively
reduce sterilant residues to
safe levels. | Identical |
| Residue
Reduction | Automatic within the
SYSTEM 1E Processor:
Two rinses with UV treated,
dual 0.1 micron membrane
filtered water effectively
reduce sterilant residues to
safe levels. | Automatic within the
SYSTEM 1E Processor:
Two rinses with UV treated,
dual 0.1 micron membrane
filtered water effectively
reduce sterilant residues to
safe levels. | Identical |
| Device Material
Compatibility | Compatible with medical
devices as established by
testing finished flexible
endoscopes through 300 | Compatible with medical
devices as established by
testing finished flexible
endoscopes through 300 | Identical |
| Feature | Proposed
S40 Sterilant Concentrate | K161683
S40 Sterilant Concentrate | Comparison |
| | cycles and rigid devices
through 150 cycles. | cycles and rigid devices
through 150 cycles. | |
| | No functional changes have
occurred to flexible devices. | No functional changes have
occurred to flexible devices. | |
| | Some materials show
cosmetic changes such as
fading of black anodized
aluminum without harm to
the base material. | Some materials show
cosmetic changes such as
fading of black anodized
aluminum without harm to
the base material. | |
| Chemical
Monitoring | VERIFY Chemical
Indicator for the SYSTEM
1E Processor(K102217) | VERIFY Chemical
Indicator for the SYSTEM
1E Processor(K102217) | Identical |
| | Chemical reaction on
indicator pad to produce
color change. | Chemical reaction on
indicator pad to produce
color change. | Identical |
13
1 Block, S. ed., Disinfection, Sterilization, and Preservation. 5th edition, 2001.
2 Clapp et al., Free Rad. Res., (1994) 21:147-167.
3 Maillard et. al., J. Med. Microbiol (1995) 42:415-420.
4 Maillard et. al., J. Appl Bacteriol (1996) 80:540-554.
5 McDonnell et al., J. AOAC International (2000) 83:269-276.
6 McDonnell et al., J. AOAC International (2000) 83:269-276.
14
15
Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as the legally marketed predicate device (K161683), Class II (21 CFR 880.6885), product code MED.