(26 days)
Not Found
No
The document describes an automated liquid chemical sterilization system with a processor that controls the sterilization cycle. There is no mention of AI or ML in the intended use, device description, or performance studies. The system's operation appears to be based on pre-programmed parameters for dilution, temperature, and time, rather than adaptive learning or data-driven decision-making.
No.
This device is a liquid chemical sterilization system used to sterilize medical devices, not to treat or diagnose patients.
No
Explanation: The device is a sterilization system for medical instruments, not a diagnostic device. It processes medical devices to make them sterile for use, it does not diagnose medical conditions.
No
The device description clearly outlines a physical system including a processor, sterilant concentrate, trays/containers, and quick connects, indicating it is a hardware-based medical device with integrated software for control.
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 sensitive medical devices and their accessories in healthcare facilities." This describes a process for disinfecting or sterilizing medical equipment, not for performing diagnostic tests on biological samples.
- Device Description: The description focuses on the mechanism of sterilization using peracetic acid and the components involved in that process (processor, sterilant concentrate, trays, quick connects). There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on biological analysis.
The device is clearly designed for reprocessing medical instruments to make them safe for reuse, which falls under the category of medical device sterilization/disinfection, 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 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, Model P6900 (S1 endo) 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.
The S1 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. After LCS 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 S1 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 S1 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
Non-clinical performance testing was performed according to the test methodology shown in the table:
- Test: Use of new control boards
- Criterion: New control boards must fit and run all cycles without alarms
- Conclusion: Pass
- Test: Software confirmation test
- Criterion: Ensure proper version, proper operation of cycles and alarms
- Conclusion: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 28, 2023
STERIS Corporation Jennifer Nalepka Manager, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060
Re: K230582
Trade/Device Name: SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 Regulation Number: 21 CFR 880.6885 Regulation Name: Sterilant, Medical Devices, Liquid Chemical Sterilants/Disinfectants Regulatory Class: Class II Product Code: MED Dated: March 1, 2023 Received: March 2, 2023
Dear Jennifer Nalepka:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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/cfpmn/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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 -S
Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230582
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 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) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
Contact:
Jennifer Nalepka Manager, Regulatory Affairs Phone: (440) 392-7458 Email: jennifer nalepka@steris.com
March 1, 2023 Summary Date:
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
| Trade Name: | SYSTEM 1 endo Liquid Chemical Sterilant Processing
System, Model P6900 |
|------------------------|---------------------------------------------------------------------------|
| Device Class: | 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 1 endo Liquid Chemical Sterilant Processing System, Model P6900, K222615
3. Description of Device
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (S1 endo) 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.
The S1 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. After LCS 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 S1 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 S1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels. Tables 1 and 2 compare the proposed and predicate devices.
4. 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.
5
The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
5. Technical Characteristic Comparison Table
The S1 endo is the same as the predicate device with the exception of the proposed modification. A comparison between the proposed and predicate devices can be found in Table 1 and Table 2 below.
| Feature | Proposed Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System, Model P6900 | Predicate Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System, Model P6900
(K222615) | 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 | 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. | Identical |
| Feature | Proposed Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System, Model P6900 | Predicate Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System, Model P6900
(K222615) | Comparison |
| | 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. | 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. | |
| 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 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 | 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 | Identical |
| Design
Features | Microprocessor controlled unalterable and standardized | Microprocessor controlled unalterable and standardized | Identical |
| Feature | Proposed Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System, Model P6900 | Predicate Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System, Model P6900
(K222615) | Comparison |
| | 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 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 | 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 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 | |
| Cycle Parameters | | | |
| 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 |
| Feature | Proposed Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System, Model P6900 | Predicate Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System, Model P6900
(K222615) | Comparison |
| 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 |
| 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 | Uses S40 Sterilant Concentrate | 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 |
| Feature | Proposed Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System, Model P6900 | Predicate Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System, Model P6900
(K222615) | Comparison |
| 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, if using the external printer
option. | Identical |
Table 1. Processor Comparison Table.
6
7
8
9
| Table 2. S40 Sterilant Concentrate Comparison Table | ||
|---|---|---|
| Feature | Proposed Device
S40 Sterilant Concentrate | Predicate Device
S40 Sterilant Concentrate
(K222615) | Comparison |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for
Use | The SYSTEM 1E Processor
uses only S40 Sterilant
Concentrate to liquid chemically
sterilize medical devices. | The SYSTEM 1E Processor
uses only S40 Sterilant
Concentrate to liquid chemically
sterilize medical devices. | 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 4 Maillard et. al., J. Appl Bacteriol (1996) 80:540-554.
5 McDonnell et al., J. ADAC International (2000) 83:269-276.
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The proposed device has the same intended use as the predicate with the same technological characteristics. The modifications, subject of this submission, are to use control boards that have been slightly modified by using alternative, drop-in replacement components in the manufacture of the devices.
6. Summary of Non-Clinical Testing
Non-clinical performance testing was performed according to the test methodology listed below and is the same methods used to verify the original design. The testing demonstrated that the subject device met the acceptance criteria described in the standard/methodology.
12
| Test | Criterion | Conclusion |
|---|---|---|
| Use of new control boards | New control boards must fit and run all cycles without alarms | Pass |
| Software confirmation test | Ensure proper version, proper operation of cycles and alarms | Pass |
Table 3. Summary of Non-Clinical Testing
7. Conclusion
The conclusions drawn from the non-clinical performance data, the SYSTEM 1 endo Liquid Chemical Sterilant Processing System is as safe, as effective, and performs as well or better than the legally marketed predicate device K222615, Class II (21 CFR 880.6885), product code MED.