(118 days)
Not Found
No
The description focuses on automated control, user interface improvements, and data logging, with no mention of AI or ML algorithms for decision-making or analysis.
No.
This device is intended for the sterilization of medical devices, not for therapeutic use on a patient. It processes semi-critical medical devices to make them safe for use, but it does not treat or cure any medical condition.
No
Explanation: The device is described as a liquid chemical sterilant processing system intended for sterilizing medical devices. While it performs "system diagnostics," this refers to verifying its own operational status for sterilization, not diagnosing patient conditions or medical devices.
No
The device description clearly outlines hardware components like the processor, processing trays/containers, and quick connects, in addition to the software modifications. It is a system with both hardware and software elements.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "liquid chemical sterilization of cleaned, immersible, and reusable semi-critical medical devices and their accessories in healthcare facilities." This describes a process for disinfecting medical equipment, not for performing tests on biological samples to diagnose conditions.
- Device Description: The description focuses on the mechanical and chemical process of sterilization using peracetic acid and filtered water. It details the processor, sterilant concentrate, trays, and quick connects, all related to the sterilization process.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health.
Therefore, the SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a medical device used for sterilization, not an in vitro diagnostic device.
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 (comma separated list FDA assigned to the subject device)
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, cleaned semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo LCS Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects.
This submission describes modifications to the processor's user interface and controller, to be introduced in Model P6900. The modifications will provide several user convenience features as compared to the originally cleared processor. Model P6800. The advantages for users include an intuitive touchscreen display, a barcode scanner, and the ability to electronically save and download cycle data for facility records. The P6900 model utilizes an updated electronic controller and suitable software, while providing cycles for liquid chemical sterilization (LCS) and system diagnostics identical to those of the original device. The modified SYSTEM 1 endo Processor, which is computer controlled and continually monitored, provides electronic documentation of each cycle. An external printer is available for printed records, if preferred.
The SYSTEM 1 endo Processor (whether Model P6800 or P6900) is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in six (6) minutes. After liquid chemical sterilant 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 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 Quick 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 was conducted to evaluate the modified device.
- Electrical Safety Conformance and EMC: UL 61010-1, UL 61010-2-040, IEC 61326-1:2012 standards were met. Result: PASS.
- Cycle Performance Qualification: All cycle specifications were met for three (3) Liquid Chemical Sterilization and three (3) Diagnostic Cycles. 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): 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.
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.
Not Found
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
§ 880.6885 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 the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration".
January 31, 2019
STERIS Corporation Marcia Benedict Senior Director, Regulatory Affairs 5976 Heisley Rd Mentor, Ohio 44060
Re: K182827
Trade/Device Name: SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: Class II Product Code: MED Dated: January 7, 2019 Received: January 8, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmr/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,
Clarence W. Murray Iii III -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) K182827
Device Name
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
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-critive 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 Part D or SEP 331 Subsidy Payment | |
|---|---|
| Care Transition or SEP 331 Subsidy Start |
__ 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 STERIS logo. The word STERIS is in large, bold, sans-serif font. Below the word STERIS is an image of several horizontal wavy lines in blue. The lines are stacked on top of each other, creating a visual representation of water or waves.
510(k) Summary For SYSTEM 1 endo Liquid Chemical Sterilant Processing System Model P6900
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: January 31, 2019
Premarket Notification Number: K182827
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, Model P6900 |
|------------------------|---------------------------------------------------------------------------|
| 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 predicate device is the SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800 cleared under K173256.
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, cleaned semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo LCS Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects.
This submission describes modifications to the processor's user interface and controller, to be introduced in Model P6900. The modifications will provide several user convenience features as compared to the originally cleared processor. Model P6800. The advantages for users include an intuitive touchscreen display, a barcode scanner, and the ability to electronically save and download cycle data for facility records. The P6900 model utilizes an updated electronic controller and suitable software, while providing cycles for liquid chemical sterilization (LCS) and system diagnostics identical to those of the original device. The modified SYSTEM 1 endo Processor, which is computer controlled and continually monitored, provides electronic documentation of each cycle. An external printer is available for printed records, if preferred.
The SYSTEM 1 endo Processor (whether Model P6800 or P6900) is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in six (6) minutes. After liquid chemical sterilant processing, the liquid chemically sterilized articles are rinsed
5
with 0.2 micron filtered potable water and are ready for use, or may be prepared for storage.
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 Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels. Table 1 compares the proposed and predicate devices.
Indications for Use 4.
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. Technological Characteristics Comparison Table
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, identified in Table 1 below.
Table 2 is provided to demonstrate that the S40 Sterilant Concentrate in the modified processor is unchanged.
Appropriate changes are made to the processor's software and labeling as a result of the different design features identified.
6
| Feature | Proposed Device
SYSTEM 1 endo Processor
Model P6900 – K182827 | Predicate Device
SYSTEM 1 endo Processor
Model P6800 – K173256 | Comparison |
|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. | Identical |
| | 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.
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 | 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.
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. |
| Feature | Proposed Device
SYSTEM 1 endo Processor
Model P6900 – K182827 | Predicate Device
SYSTEM 1 endo Processor
Model P6800 – K173256 | Comparison |
| 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: | • Electronic and/or printed
cycle records document
successful cycle completion
or identify 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
• 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 in
Diagnostic Cycle | • 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
• 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 in
Diagnostic Cycle | Identical,
except cycle
records are
electronic |
| 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 | • 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 | The proposed
device uses
an updated
controller and
its respective
software to
provide
identical
processing
parameters.
The proposed
device uses
an updated
touchscreen |
| Feature | Proposed Device
SYSTEM 1 endo Processor
Model P6900 – K182827 | Predicate Device
SYSTEM 1 endo Processor
Model P6800 – K173256 | Comparison |
| | filtered through a 0.2 micron
membrane air filter Includes a barcode scanner; employs touchscreen display interface; has USB drive for electronic cycle download; facilitates use of a web-based data management system. Separate, optional printer | filtered through a 0.2 micron
membrane air filter Has no barcode scanner, employs a membrane touch panel interface and small display, has no USB drive. Includes an onboard printer for cycle information | barcode reader and USB drive for electronic cycle records, and facilitates use of a web-based data mgmt system. Use of printer is optional. |
| Cycle Parameters | | | Comparison |
| Incoming
water temp. | $\geq$ 43°C | $\geq$ 43°C | Identical |
| Temperature
to start
sterilant
exposure | $\geq$ 46°C | $\geq$ 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 |
| 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 is filtered through 0.2 micron bacterial retentive membrane filter | 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 |
| Internal
Water Filter
Integrity Test | Conducted during the Diagnostic
cycle | Conducted during the Diagnostic
cycle | Identical |
| Approximate
Cycle Time | 18 - 20 minutes | 18 - 20 minutes | Identical |
| Feature | Proposed Device
SYSTEM 1 endo Processor
Model P6900 – K182827 | Predicate Device
SYSTEM 1 endo Processor
Model P6800 – K173256 | Comparison |
| 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 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. | Identical |
| Accessories | | | |
| 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
• Ultrasound Processing Tray | Uses interchangeable processing
trays/containers
• Universal Flex Processing Tray
• General Processing Container
& Tray
• Directed Flow Processing
Container & Tray
• Flexible Endoscope Processing
Container & Tray
• Ultrasound Processing Tray | Identical |
| 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 for
S40 Sterilant is available for use
in SYSTEM 1 endo LCSPS | VERIFY Chemical Indicator for
S40 Sterilant is available for use
in SYSTEM 1 endo LCSPS | Identical |
| Spore Test
Strip | VERIFY Spore Test Strip for S40
Sterilant for use in SYSTEM 1
endo LCSPS | VERIFY Spore Test Strip for S40
Sterilant for use in SYSTEM 1
endo LCSPS | Identical |
| Operator
Maintenance | Periodic replacement of water
filters and air filter.
Periodic replacement of printer
tape, if using the external printer
option. | Periodic replacement of water
filters and air filter.
Periodic replacement of printer
tape. | Identical,
excepting that
the printer is
an external
option |
| Feature | S40 Sterilant Concentrate
in S1 endo LCSPS
Model P6900 – K182827 | S40 Sterilant Concentrate
in S1 endo LCSPS
Model P6800 - K173256 | Comparison |
| Intended Use | For use in S1E or S1 endo
LCSPS | For use in S1E or S1 endo
LCSPS | Identical |
| 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 S1 endo LCSPS | Identical |
| Cytotoxicity
Device
Extracts | Two Processor controlled rinses
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, dual 0.2 micron
filtered potable water effectively
reduce sterilant residues to non-
cytotoxic levels. | Identical |
| Residue
Reduction | Two Processor controlled rinses
with pre-filtered, dual 0.2
micron filtered potable water
effectively reduce sterilant
residues to safe levels. | Two Processor controlled rinses
with pre-filtered, dual 0.2 micron
filtered potable water effectively
reduce sterilant residues to safe
levels. | Identical |
| 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 |
Table 1. Processor Comparison Table
7
8
9
10
Table 2. S40 Sterilant Concentrate Comparison Table
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
11
5 McDonnell et al., J. AOAC International (2000) 83:269-275
12
13
Summary of Non-Clinical Performance Testing 6.
Performance testing was conducted to evaluate the modified device and the results are summarized in Table 3.
| Test | Acceptance Criteria | Result |
|---|---|---|
| Electrical Safety | ||
| Conformance | ||
| and EMC | UL 61010-1 Safety Requirements for Electrical | |
| Equipment for Measurement, Control, and Laboratory | ||
| Use – Part 1: General Requirements, 3rd Edition | ||
| UL 61010-2-040 Safety Requirements for Electrical | ||
| Equipment for Measurement, Control, and Laboratory | ||
| Use – Part 2-040: Particular Requirements for | ||
| Sterilizers and Washer-Disinfectors Used to Treat | ||
| Medical Materials, 2nd Edition | ||
| IEC 61326-1:2012 Electrical equipment for | ||
| measurement, control and laboratory use – EMC | ||
| Requirements – Part 1: General Requirements | PASS | |
| Cycle | ||
| Performance | ||
| Qualification | All cycle specifications were met for three (3) Liquid | |
| Chemical Sterilization and three (3) Diagnostic | ||
| Cycles. | PASS | |
| Software | ||
| Validation | The software that controls the system was validated | |
| and determined to operate effectively and as designed. | PASS |
Table 3. Performance Testing Summary Table
7. 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 or better than the legally marketed predicate device (K173256).