(143 days)
No
The description mentions the device is "computer controlled and continually monitored" and has "Software Validation," but there is no mention of AI, ML, or any learning or adaptive capabilities. The system appears to follow a predefined, automated process.
No
This device is a liquid chemical sterilization system used to sterilize medical devices, not treat patients.
No
The device is a sterilizer for medical devices, not a diagnostic device. Its purpose is to clean and sterilize heat-sensitive medical instruments.
No
The device is described as a "Liquid Chemical Sterilant Processing System" consisting of a "Processor" (an automated, self-contained device), sterilant concentrate, trays/containers, and quick connects. While it is computer-controlled and has validated software, it is fundamentally a hardware system designed for physical sterilization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories in healthcare facilities." This describes a process for preparing medical devices for use, not for performing diagnostic tests on biological samples.
- Device Description: The description details a system for sterilizing medical instruments using a chemical process. It does not mention analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
The device is clearly intended for the reprocessing of medical devices to prevent the spread of infection, which falls under the category of medical device sterilization, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories in healthcare facilities.
The SYSTEM 1 endo Processor automatically 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 0.2 micron filtered water.
The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
Product codes
MED
Device Description
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects.
This new liquid chemical sterilant processing system is based substantially on the predicate device, which was most recently cleared via K170956.
The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle. The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - 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 semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Ouick Connects, if required, facilitate delivery of the sterilant use-solution 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing
- In-Use Testing: Clinically used, cleaned semi-critical heat-sensitive medical devices exposed to varied clinical soils were effectively liquid chemically sterilized. Result: PASS.
- Electrical Safety Conformance: Conformance to UL 61010-1:2012 Ed.3+R:29 Apr2016 and UL 61010-2-040:2016 Ed.2. Result: PASS.
- Water Filter Performance through Use Life: The 0.2 micron MaxLife filter maintained its integrity and achieved effective bacterial retention performance after numerous Liquid Chemical Sterilization Cycles and Diagnostic Cycles representing 6 months of active use. Result: PASS.
- Water Filter Integrity Test: The Diagnostic Cycle correctly detects loss of filter integrity or absence of a filter. Result: PASS.
- Cycle Qualification: All cycle specifications were met for three (3) cycles each, Liquid Chemical Sterilization and Diagnostic. Result: PASS.
- Software Validation: The software that controls the system was validated and determined to operate effectively and as designed. Result: PASS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K090036, K101409, K102462, K110352, K131078, K161683, K102217, DEN110002
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/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
March 2, 2018
Steris Corporation Marcia Benedict Senior Director, Regulatory Affairs 5976 Heisley Rd Mentor, Ohio 44060
Re: K173256
Trade/Device Name: System 1 endo 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: January 31, 2018 Received: February 1, 2018
Dear Marcia Benedict:
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 manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 mediation-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)
Device Name
SYSTEM 1 endo Liquid Chemical Sterilant Processing System
Indications for Use (Describe)
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories in healthcare facilities.
The SYSTEM 1 endo Processor automatically 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 0.2 micron filtered water.
The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
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
510(k) Summary For SYSTEM 1 endo Liquid Chemical Sterilant Processing System
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact:
Marcia Benedict Senior Director, Regulatory Affairs Tel: 440-392-7063 Fax: 440-357-9198
Submission Date: February 26, 2018
Premarket Notification Number: K173256
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
1. Device Name
| Trade Name: | SYSTEM 1 endo Liquid Chemical Sterilant
Processing System |
|------------------------|-------------------------------------------------------------------------|
| Device Class: | Class 2 |
| 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
The claimed primary predicate device is the SYSTEM 1E Liquid Chemical Sterilant Processing System, cleared most recently under K170956.
The S1E prior clearances include Premarket submissions K090036, K101409. K102462, K110352, K131078, K161683.
3. Description of Device
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects.
This new liquid chemical sterilant processing system is based substantially on the predicate device, which was most recently cleared via K170956.
The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle. The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - 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 semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Ouick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels. Table 1 compares the proposed and predicate devices.
5
4. Intended Use
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heatsensitive medical devices and their accessories in healthcare facilities.
The SYSTEM 1 endo Processor automatically 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 0.2 micron filtered water.
The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
5. Description of Technological Similarities and Differences
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is the same as the predicate device except for the specific differences described in this submission. The differences between the proposed and predicate devices, identified in Table 1 and 2 below, include use of a 0.2 micron bacterial retentive water filter in place of the predicate's extensive water treatment process. Appropriate changes are made to software and labeling as a result. These differences raise no new concerns of safety and effectiveness when compared to the predicate device.
| Feature | Proposed Device
SYSTEM 1 endo Processor
(K173256) | Predicate Device
SYSTEM 1E Processor
(K170956) | Comparison |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System is intended for liquid
chemical sterilization of cleaned,
immersible, and reusable semi-
critical heat-sensitive medical
devices and their accessories 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 S1 endo
LCSPS's
intended use is
limited to
semi-critical
medical
devices and
their
accessories. |
| Indications
for Use | The SYSTEM 1 endo Processor
automatically 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 0.2 | 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 | |
| Feature | Proposed Device
SYSTEM 1 endo Processor
(K173256) | Predicate Device
SYSTEM 1E Processor
(K170956) | Comparison |
| | micron filtered water.
The SYSTEM 1 endo Processor
uses only S40 Sterilant
Concentrate to liquid chemically
sterilize medical devices. | 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 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 Device
SYSTEM 1 endo Processor
(K173256) | Predicate Device
SYSTEM 1E Processor
(K170956) | 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, i.e. Quick
Connects.
S40 Sterilant 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. | 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, i.e. Quick
Connects.
S40 Sterilant 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. | Identical,
except that the
proposed
device uses
0.2 micron
filtered water
in place of
extensively
treated water. |
| | The processor monitors and
controls the use dilution
temperature and contact time. The
processor automatically rinses the
load with 0.2 micron filtered
water to remove sterilant
residuals. | The processor monitors and
controls the use dilution
temperature and contact time. The
processor automatically rinses the
load with extensively treated
filtered water to remove sterilant
residuals. | |
| Process
Parameters | Standardized cycle parameters
cannot be altered by operator. The
critical process parameters are:
• Use dilution contact time
• Use dilution temperature
• Peracetic acid concentration
• Integrity of the internal water
filter (tested by the system) | Standardized cycle parameters
cannot be altered by operator. The
critical process parameters are:
• Use dilution contact time
• Use dilution temperature
• Peracetic acid concentration
• Integrity of the internal water
filter (tested by the system) | 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
• Alarms if conductivity probe
indicated conductivity
specification not met | • 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
• Alarms if conductivity probe
indicated conductivity
specification not met | Identical,
except there is
no UV system
intensity to be
monitored in
the proposed
device. |
| Feature | Proposed Device
SYSTEM 1 endo Processor
(K173256) | Predicate Device
SYSTEM 1E Processor
(K170956) | Comparison |
| | Alarms if pressure transducer
indicates circulation pressure
is out of specification in
Diagnostic cycle
Alarms if pressure transducer
●
indicates internal water filter
failed integrity test | Alarms if pressure transducer
indicates circulation pressure
is out of specification in
Diagnostic cycle
Alarms if pressure transducer
indicates internal water filter
failed integrity test
Alarms if UV monitor
indicates UV intensity out of
specification | |
| Design
Features | Microprocessor controlled
●
unalterable and standardized
liquid chemical sterilization
and Diagnostic cycles
Intended for use only with
●
S40 Sterilant Concentrate
Automated dilution and
●
delivery of S40 Sterilant
Processor provides 0.2 micron
●
filtered water for liquid
chemical sterilization and
rinsing
Make-up air for processor
●
during drain sequences is
filtered through a 0.2 micron
membrane air filter | Microprocessor controlled
unalterable and standardized
liquid chemical sterilization
and Diagnostic cycles
Intended for use only with
S40 Sterilant Concentrate
Automated dilution and
delivery of S40 Sterilant
· Processor provides
extensively treated (UV
irradiated, 0.1 micron filtered)
water for liquid chemical
sterilization and rinsing
Make-up air for processor
during drain sequences is
filtered through a 0.2 micron
membrane air filter | Identical,
except that
the proposed
device uses
0.2 micron
filtered water
in place of
extensively
treated water. |
| Cycle Parameters | | | Comparison |
| Incoming
water temp. | > 43°C | > 43°C | Identical |
| Temperature
to start
sterilant
exposure | > 46°C | > 46°C | Identical |
| Temperature
alarm point
during LCS
exposure | 60°C | 60°C | Identical |
| Temperature
range of
typical LCS
cycle | 46 - 55°C | 46 - 55°C | Identical |
| Exposure
Time - S40
use dilution | 6 minutes | 6 minutes | Identical |
| Feature | Proposed Device
SYSTEM 1 endo Processor
(K173256) | Predicate Device
SYSTEM 1E Processor
(K170956) | Comparison |
| Rinse water
preparation | Hot potable tap water
• is pre-filtered
• is filtered through 0.2 micron
bacterial retentive membrane
filter | Hot potable tap water
• is pre-filtered
• flows through a UV light
water treatment chamber to
achieve > a 6-log reduction
of virus
• is filtered through redundant
0.1 micron membranes | The proposed
device uses
0.2 micron
filtered water
in place of
extensively
treated water. |
| 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 |
| Internal
Water Filter
Integrity Test | Conducted during the Diagnostic
cycle | Conducted at the end of every
Liquid Chemical Sterilization
cycle and during the Diagnostic
cycle | Only in
Diagnostic
Cycle of S1
endo LCSPS |
| Approximate
Cycle Time | 18 - 20 minutes | 23 - 25 minutes | S1 endo has
shorter total
cycle time |
| Diagnostic
Cycle | Performs 14 tests on processor's
systems confirming proper
function. Recommended to
perform each day of use. After a
failed Diagnostic cycle, a liquid
chemical sterilization 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. Recommended to
perform each day of use. After a
failed Diagnostic cycle, a liquid
chemical sterilization cycle
cannot be performed until the
problem is rectified and a
successful Diagnostic cycle has
been completed. | Identical
except that
proposed S1
endo LCSPS
has no UV
unit test |
| Accessories | | | Comparison |
| Sterilant | Uses S40 Sterilant Concentrate -
see Table 2 | Uses S40 Sterilant Concentrate -
see Table 2 | Identical |
| Processing
Trays and
Containers | Uses interchangeable processing
trays/containers
• Universal Flex Processing Tray
• General Processing Container
& Tray
• Directed Flow Processing
Container & Tray
• Flexible Endoscope Processing
Container & Tray | Uses interchangeable processing
trays/containers
• Universal Flex Processing Tray
• General Processing Container
& Tray
• Directed Flow Processing
Container & Tray
• Flexible Endoscope Processing
Container & Tray | Identical |
| Feature | Proposed Device
SYSTEM 1 endo Processor
(K173256) | Predicate Device
SYSTEM 1E Processor
(K170956) | Comparison |
| | • Ultrasound Processing Tray | • Ultrasound Processing Tray | |
| Quick
Connects | Uses Quick Connects to attach
instrument lumens to the
Tray/Container ports | Uses Quick Connects to attach
instrument lumens to the
Tray/Container ports | Identical |
| Chemical
Indicator | VERIFY Chemical Indicator is
available for use in SYSTEM 1
endo LCSPS (separate clearance) | VERIFY Chemical Indicator is
available for SYSTEM 1E
(K102217) | Identical
design |
| Spore Test
Strip | VERIFY Spore Test Strip for S40
Sterilant for use in SYSTEM 1
endo LCSPS (separate clearance) | VERIFY Spore Test Strip for S40
Sterilant (DEN110002) | Identical
design |
| Operator
Maintenance | Periodic replacement of printer
tape, water filters and air filter | Periodic replacement of printer
tape, water filters and air filter | Identical |
Table 1. Processor Comparison Table
6
7
8
9
10
Table 2. S40 Sterilant Concentrate Comparison Table
| Feature | S40 Sterilant Concentrate
in S1 endo LCSPS (K173256) | S40 Sterilant Concentrate
in S1E LCSPS (K170956) | Comparison |
|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Intended Use | For use in S1E and S1 endo | For use in S1E only | Adds a new
intended use |
| Germicidal
claim | Liquid Chemical Sterilant | Liquid Chemical Sterilant | Identical |
| Exposure
Time | 6 minutes | 6 minutes | Identical |
| Use
Temperature | 45.5 - 60°C - allowable range
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 in S1 endo LCSPS | No surviving microorganisms on
representative medical devices
tested in S1E LCSPS | Identical |
| Cytotoxicity
Device
Extracts | Two Processor controlled rinses
(time, temperature, and volume
equivalent to predicate) with
pre-filtered, dual 0.2 micron
filtered potable water effectively
reduce sterilant residues to non-
cytotoxic levels. | Two Processor controlled rinses
with pre-filtered, UV treated, dual
0.1 micron membrane filtered
potable water effectively reduce
sterilant residues to non-cytotoxic
levels. | Identical |
| Residue
Reduction | Two Processor controlled rinses
(time, temperature, and volume
equivalent to predicate) with
pre-filtered, dual 0.2 micron
filtered potable water effectively
reduce sterilant residues to safe
levels. | Two Processor controlled rinses
with pre-filtered, UV irradiated,
dual 0.1 micron membrane filtered
potable water effectively reduce
sterilant residues to safe levels. | Identical |
| Feature | S40 Sterilant Concentrate
in S1 endo LCSPS (K173256) | S40 Sterilant Concentrate
in S1E LCSPS (K170956) | Comparison |
| Material
Compatibility | Compatible with medical
devices as established by testing
finished medical devices through
300 cycles. No functional
changes occurred to devices.
Some materials show cosmetic
changes such as fading of
external markings (yet all
remained legible) and bleaching
of black anodized aluminum
without harm to the base
material. | Compatible with medical devices
as established by testing finished
medical devices through 300
cycles. No functional changes
occurred to devices. Some
materials show cosmetic changes
such as fading of external
markings (yet all remained
legible) and bleaching of black
anodized aluminum without harm
to the base material. | Identical |
11
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) 83:269-275
12
13
6. Description of Safety and Substantial Equivalence
The SYSTEM endo Liquid Chemical Sterilant Processing System is the same as the predicate device except for the specific differences described in this submission and identified in Tables 1 and 2.
The proposed device and its predicate have similar intended use and technological characteristics. The differences raise no new concerns of safety and effectiveness when compared to the predicate device. New testing was performed to evaluate and demonstrate substantial equivalence to the predicate as summarized in Table 3.
| Test | Acceptance Criteria | Result |
|---|---|---|
| In-Use Testing | Clinically used, cleaned semi-critical heat-sensitive | |
| medical devices exposed to varied clinical soils were | ||
| effectively liquid chemically sterilized. | PASS | |
| Electrical Safety | ||
| Conformance | UL 61010-1:2012 Ed.3+R:29 Apr2016 Electrical | |
| Equipment for Measurement, Control, and Laboratory | ||
| Use Part 1: General Requirements | ||
| UL 61010-2-040:2016 Ed.2 Electrical Equipment For | ||
| Measurement, Control, And Laboratory Use Part 2-040: | ||
| Particular Requirements For Sterilizers And Washer- | ||
| Disinfectors Used To Treat Medical Materials | PASS | |
| Water Filter | ||
| Performance | ||
| through Use Life | The 0.2 micron MaxLife filter maintained its integrity | |
| and achieved effective bacterial retention performance | ||
| after numerous Liquid Chemical Sterilization Cycles and | ||
| Diagnostic Cycles representing 6 months of active use. | PASS | |
| Water Filter | ||
| Integrity Test | The Diagnostic Cycle correctly detects loss of filter | |
| integrity or absence of a filter. | PASS |
Table 3. Performance Testing
14
| Cycle
Qualification | All cycle specifications were met for three (3) cycles
each, Liquid Chemical Sterilization and Diagnostic. | PASS |
|------------------------|---------------------------------------------------------------------------------------------------------------|------|
| Software
Validation | The software that controls the system was validated and
determined to operate effectively and as designed. | PASS |
7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs at least as well as the legally marketed predicate device (K170956), Class II (21 CFR 880.6885), product code MED.