Who is the manufacturer of SYSTEM 1E Liquid Chemical Sterilant Processing System?

Steris Corporations filed the 510(k) submission for SYSTEM 1E Liquid Chemical Sterilant Processing System (K180342).

What is the FDA product code for SYSTEM 1E Liquid Chemical Sterilant Processing System?

MED. It is classified under 21 CFR 880.6885 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for SYSTEM 1E Liquid Chemical Sterilant Processing System?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like SYSTEM 1E Liquid Chemical Sterilant Processing System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SYSTEM 1E Liquid Chemical Sterilant Processing System

K180342 · Steris Corporations · MED · Apr 4, 2018 · General Hospital

Device Facts

Record ID	K180342
Device Name	SYSTEM 1E Liquid Chemical Sterilant Processing System
Applicant	Steris Corporations
Product Code	MED · General Hospital
Decision Date	Apr 4, 2018
Decision	SESE
Submission Type	Special
Regulation	21 CFR 880.6885
Device Class	Class 2

Intended Use

The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities. The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use. The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

Device Story

Automated, self-contained liquid chemical sterilization system; processes immersible, heat-sensitive medical devices (flexible/rigid endoscopes, microsurgical instruments). Input: S40 Sterilant Concentrate (peracetic acid) and EPA potable water. Operation: Processor dilutes sterilant; maintains 45.5-60°C for 6-minute exposure; performs two-stage rinse with UV-treated, 0.1-micron filtered water. Used in healthcare facilities; operated by staff. Output: Sterilized devices and printed cycle documentation. System monitors cycle parameters (time, temperature, concentration, filter integrity) via microprocessor; provides alarms for out-of-spec conditions. Benefits: Enables sterilization of heat-sensitive instruments; ensures residue removal via automated rinsing.

Clinical Evidence

No clinical data. Bench testing only. Verification activities included microbial retention challenges per ASTM F838-15, cycle accumulation testing to represent 3-month use life, and peracetic acid concentration stability testing. All tests met acceptance criteria.

Technological Characteristics

Microprocessor-controlled liquid chemical sterilizer. Uses peracetic acid (S40 Sterilant Concentrate). Water treatment: 2.5-micron depth filter, 0.1-micron surface filter, UV irradiation (>6-log reduction of MS2 virus), and redundant 0.1-micron absolute-rated membrane filters. Connectivity: Printed cycle documentation. Sterilization: 6-minute exposure at 45.5-60°C. Materials: Interchangeable processing trays/containers. Software: Locked, standardized, unalterable cycles.

Indications for Use

Indicated for liquid chemical sterilization of cleaned, immersible, reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

SYSTEM 1E Liquid Chemical Sterilant Processing System (K170956)

Related Devices

K170956 — SYSTEM 1E Liquid Chemical Sterilant Processing System · STERIS Corporation · Sep 22, 2017
K131078 — SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM · STERIS Corporation · Jul 5, 2013
K090036 — SYSTEM 1.5 STERILE PROCESSING SYSTEM · STERIS Corporation · Apr 5, 2010
K102462 — SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM · STERIS Corporation · Sep 21, 2010
K113520 — SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM · STERIS Corporation · Feb 21, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION". April 4, 2018 Steris Corporations Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060 Re: K180342 Trade/Device Name: SYSTEM 1E Liquid Chemical Sterilant Processing System Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: Class II Product Code: MED Dated: March 12, 2018 Received: March 13, 2018 Dear Jennifer Nalepka: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good 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) K180342 ### Device Name SYSTEM 1E Liquid Chemical Sterilant Processing System Indications for Use (Describe) The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities. The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use. The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices. * The extensive treatment of EPA potable water consists of: - 1. Pre-filtration through two pre-filters: - · Pre-filter A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants. - · Pre-filter B is a surface filter that removes particles/contaminants > 0.1 micron. - 2. UV Irradiation: - · During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water. - 3.0.1 micron filtration: · The water prepared by pre-filtration is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for STERIS. The word "STERIS" is written in a serif font in all capital letters. Below the word is an image of several horizontal wavy lines in blue. # 510(k) Summary For SYSTEM 1E Liquid Chemical Sterilant Processing System STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Contact: Jennifer Nalepka Senior Regulatory Affairs Specialist Tel: 440-392-7458 Fax: 440-357-9198 March 27, 2018 Summary Date: Premarket Notification Number: K180342 STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 {4}------------------------------------------------ #### 1. Device Name | Trade Name: | SYSTEM 1E Liquid Chemical Sterilant Processing System | |------------------------|-------------------------------------------------------------------------| | Device Classification: | Class II | | Common/usual Name: | Liquid Chemical Sterilizer | | Classification Name: | Sterilant, Medical devices, Liquid Chemical Sterilants/Disinfectants | | Classification Number: | 21 CFR 880.6885 | | Product Code: | MED | #### 2. Predicate Device SYSTEM 1E Liquid Chemical Sterilant Processing System cleared under K170956 #### 3. Description of Device The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects. The device was originally cleared under K090036. Six Special 510(k)s were cleared that subsequently made minor modifications to hardware, software, specifications, labeling, sterilant and accessories. A Traditional 510(k) was cleared in 2017 adding a new Ultrasound Processing Tray C3000XL and modifying the Indications for Use. The current submission is provided to describe the addition of a second supplier for bacterial retentive water filter, referred to in labeling as the MaxPure filter and A and B Pre-filters and to add an alternate resin for the construction of the sterilant capsule. The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment subsystem, and then through two 0.1micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle. {5}------------------------------------------------ S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed exclusively for use in the SYSTEM 1E Processor. The active ingredient in S40 Sterilant Concentrate, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials. The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects for the SYSTEM 1E Processor, if required, facilitate delivery of the liquid chemical sterilant use dilution and rinse water to internal channels. #### 4. Intended Use The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semicritical heat-sensitive medical devices in healthcare facilities. The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use. The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices. - 米 The extensive treatment of EPA potable water consists of: - 1. Pre-filtration through two pre-filters: - Pre-filter A is a gross depth filter that removes approximately 2.5 . micron or larger particles/contaminants. - Pre-filter B is a surface filter that removes particles/contaminants > . 0.1 micron. - 2. UV Irradiation: - During transit through the UV water treatment chamber, a UV dose . sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water. - 3. 0.1 micron filtration: - The water prepared by pre-filtration and UV irradiation is filtered ● through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron. {6}------------------------------------------------ #### 5. Description of Technological Similarities and Differences The SYSTEM 1E Liquid Chemical Sterilant Processing System is the same as the predicate device except for the specific modification described in this submission. The differences between the proposed and predicate devices are limited to the addition of an alternate supplier for the MaxPure Filter and A and B Pre-filters and to add an alternate resin for the construction of the sterilant capsule. These proposed changes raise no new concerns of safety and effectiveness when compared to the predicate device. # Device Comparison Table | Feature | Proposed SYSTEM 1E Processor | K170956 SYSTEM 1E Processor | Comparison | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Indications for Use | The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi- critical heat-sensitive medical devices in healthcare facilities. The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60℃, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi- critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use. | The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi- critical heat-sensitive medical devices in healthcare facilities. The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60℃, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi- critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use. | Identical | | Table 6-1. Processor Device Comparison Table | | | | | | |-----------------------------------------------|--|--|--|--|--| |-----------------------------------------------|--|--|--|--|--| {7}------------------------------------------------ | Feature | Proposed SYSTEM 1E Processor | K170956 SYSTEM 1E Processor | Comparison | | | | |----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | 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. | | | | | | | * The extensive treatment of EPA potable water consists of: 1. Pre-filtration through two pre-filters: • Pre-filter A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants. • Pre-filter B is a surface filter that removes particles/contaminants > 0.1 micron. | * The extensive treatment of EPA potable water consists of: 1. Pre-filtration through two pre-filters: • Pre-filter A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants. • Pre-filter B is a surface filter that removes particles/contaminants > 0.1 micron. | | | | | | | 2. UV Irradiation: • During transit through the UV water treatment chamber, a UV dose sufficient to achieve a ≥ 6-log reduction of MS2 virus is delivered to the water. | 2. UV Irradiation: • During transit through the UV water treatment chamber, a UV dose sufficient to achieve a ≥ 6-log reduction of MS2 virus is delivered to the water. | | | | | | | 3. 0.1-micron filtration: • The water prepared by pre-filtration and UV irradiation is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron | 3. 0.1-micron filtration: • The water prepared by pre-filtration and UV irradiation is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron | | | | | | Feature | Proposed SYSTEM 1E Processor | K170956 SYSTEM 1E Processor | Comparison | | | | | Operating Principles/ Technology | A microprocessor controlled unit with interchangeable processing trays/containers. The processor lid opens to reveal the processing chamber in which the load is placed. Devices with internal lumens are interfaced with the processor using connectors. Sterilant Concentrate is placed in a specialized compartment and when the processor fills with water, it creates the sterilant use dilution from the single use sterilant cup. The processor monitors and controls the use dilution temperature and contact time. The processor automatically rinses the load with extensively treated water to remove sterilant residuals. | A microprocessor controlled unit with interchangeable processing trays/containers. The processor lid opens to reveal the processing chamber in which the load is placed. Devices with internal lumens are interfaced with the processor using connectors. Sterilant Concentrate is placed in a specialized compartment and when the processor fills with water, it creates the sterilant use dilution from the single use sterilant cup. The processor monitors and controls the use dilution temperature and contact time. The processor automatically rinses the load with extensively treated water to remove sterilant residuals. | Identical | | | | | | Process Parameters | Standardized cycle parameters cannot be altered by operator. The critical process parameters are: ● Contact Time ● Use Dilution Temperature ● Peracetic acid concentration ● Bacterial retentive water filter integrity ● UV irradiation | Standardized cycle parameters cannot be altered by operator. The critical process parameters are: ● Contact Time ● Use Dilution Temperature ● Peracetic acid concentration ● Bacterial retentive water filter integrity ● UV irradiation | Identical | | | | | | Process Monitors | ● Cycle Printout documents successful cycle completion or identifies fault if cycle aborts ● Alarms if thermocouples indicate temperature out of specification ● Alarms if pressure switch indicates that high pressure pump is not operating | ● Cycle Printout documents successful cycle completion or identifies fault if cycle aborts ● Alarms if thermocouples indicate temperature out of specification ● Alarms if pressure switch indicates that high pressure pump is not operating | Identical | | | | | | Feature | Proposed SYSTEM 1E Processor | K170956 SYSTEM 1E Processor | Comparison | | | | | Design Features | probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification during Diagnostic cycle Alarms if pressure transducer indicates 0.1-micron water filter failed integrity test during liquid chemical sterilant processing and Diagnostic cycles. Alarms if UV monitor indicates UV intensity out of specification Microprocessor controlled unalterable and standardized liquid chemical sterilant processing and Diagnostic cycles Intended for use with S40 Sterilant Concentrate Processor provides dual 0.1 micron filtered, UV treated water for liquid chemical sterilant processing and rinsing Automated dilution and delivery of sterilant Make up air for processor during drain sequences is filtered through a 0.2-micron membrane air filter. | probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification during Diagnostic cycle Alarms if pressure transducer indicates 0.1-micron water filter failed integrity test during liquid chemical sterilant processing and Diagnostic cycles. Alarms if UV monitor indicates UV intensity out of specification Microprocessor controlled unalterable and standardized liquid chemical sterilant processing and Diagnostic cycles Intended for use with S40 Sterilant Concentrate Processor provides dual 0.1 micron filtered, UV treated water for liquid chemical sterilant processing and rinsing Automated dilution and delivery of sterilant Make up air for processor during drain sequences is filtered through a 0.2-micron membrane air filter. | Identical | | | | | Processing Cycle | | | | | | | | Incoming water temperature | $\geq 43°C$ | $\geq 43°C$ | Identical | | | | Temperature to start exposure phase | $\geq 46°C$ | $\geq 46°C$ | Identical | | | | Feature | Proposed SYSTEM 1E Processor | K170956 SYSTEM 1E Processor | Comparison | | | | | Temperature alarm point during the exposure phase | <45.5 or >60°C | <45.5 or >60°C | Identical | | | | Temperature range during a typical Liquid Chemical Sterilant Processing Cycle | 46 - 55°C | 46 - 55°C | Identical | | | | | Exposure Time | 6 minutes | 6 minutes…

SYSTEM 1E Liquid Chemical Sterilant Processing System

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

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SYSTEM 1E Liquid Chemical Sterilant Processing System

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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