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

STERIS Corporation filed the 510(k) submission for SYSTEM 1E Liquid Chemical Sterilant Processing System (K170956).

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: Traditional).

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

K170956 · STERIS Corporation · MED · Sep 22, 2017 · General Hospital

Device Facts

Record ID	K170956
Device Name	SYSTEM 1E Liquid Chemical Sterilant Processing System
Applicant	STERIS Corporation
Product Code	MED · General Hospital
Decision Date	Sep 22, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6885
Device Class	Class 2

Indications for Use

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

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-irradiated, 0.1-micron filtered water. Output: Sterilized devices; printed cycle documentation. Used in healthcare facilities; operated by clinical staff. Processor monitors cycle parameters (temperature, contact time, sterilant concentration, filter integrity, UV intensity). Provides automated, unalterable processing cycles. Benefits: Enables rapid sterilization of heat-sensitive instruments; ensures consistent, validated sterilization conditions; reduces manual handling of chemical sterilants.

Clinical Evidence

Bench testing only. Efficacy validated via AOAC Official Methods (966.04, 955.17, 955.14, 955.15, 964.02) and EPA virucidal testing. Simulated-use testing demonstrated >6-log10 reduction of Geobacillus stearothermophilus spores. Material compatibility confirmed through 300 cycles for flexible endoscopes and 150 cycles for rigid devices.

Technological Characteristics

Microprocessor-controlled liquid chemical sterilizer. Uses peracetic acid (S40 Sterilant Concentrate). Water treatment: pre-filtration (2.5 micron and 0.1 micron), UV irradiation (>6-log reduction of MS2 virus), and redundant 0.1-micron absolute membrane filtration. Cycle: 6-minute exposure at 45.5–60°C. Connectivity: Printed cycle documentation. Components: Interchangeable processing trays/containers and Quick Connects.

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 (K161683)

Reference Devices

VERIFY Chemical Indicator for the SYSTEM 1E Processor (K102217)
VERIFY Spore Test Strip for S40 Sterilant Concentrate (K100049)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and are arranged in a way that suggests movement or flow. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 22, 2017 Steris Corporation Tricia Cregger Senior Manager, Regulatory Affairs 5960 Heisley Rd Mentor. Ohio 44060 Re: K170956 Trade/Device Name: System 1E Liquid Chemical Sterilant Processing System Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: Class II Product Code: MED Dated: August 25, 2017 Received: August 28, 2017 Dear Tricia Cregger: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Tara A. Ryan -S 2017.09.22 19:20:55 -04'00' for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K170956 #### Device Name SYSTEM 1E Liquid Chemical Sterilant Processing System #### Indications for Use (Describe) The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities. The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use. The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liguid chemically sterilize medical devices. * The extensive treatment of EPA potable water consists of: 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. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for STERIS. The word "STERIS" is written in a serif font in all capital letters. Below the word is a graphic of several horizontal wavy lines in blue. The registered trademark symbol is to the right of the word STERIS. # 510(k) Summary For SYSTEM 1E Liquid Chemical Sterilant Processing System STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Tricia Cregger, Ph. D. Contact: Senior Manager, Regulatory Affairs Tel: 440-392-7189 Fax: 440-357-9198 September 22, 2017 Summary Date: Premarket Notification Number: K170956 STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 {4}------------------------------------------------ #### 1. Device Name | Trade Name: | SYSTEM 1E Liquid Chemical Sterilant Processing System | |------------------------|-------------------------------------------------------------------------| | Device Classification: | Class II | | Common/usual Name: | Liquid Chemical Sterilizer | | Classification Name: | Sterilant, Medical devices, Liquid Chemical Sterilants/Disinfectants | | Classification Number: | 21 CFR 880.6885 | | Product Code: | MED | #### 2. Predicate Device SYSTEM 1E Liquid Chemical Sterilant Processing System cleared under K161683 #### 3. Description of Device The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects. The device was originally cleared under K090036. Five Special 510(k)s were cleared that subsequently made minor modifications to hardware, software, specifications, and labeling. This premarket notification introduces a new processing tray that will accommodate ultrasound endoscopes and other large flexible devices and their associated Quick Connects. Additionally, minor inconsistent statements in the cleared Indications for Use are corrected, and clarification is provided on post-processing handling and storage of critical and semi-critical medical devices. The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment subsystem, and then through two 0.1 micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle. {5}------------------------------------------------ S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed exclusively for use in the SYSTEM 1E Processor. The active ingredient in S40 Sterilant Concentrate, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials. The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects for the SYSTEM 1E Processor, if required, facilitate delivery of the liquid chemical sterilant use dilution and rinse water to internal channels. #### 4. Intended Use The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semicritical heat-sensitive medical devices in healthcare facilities. The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use. The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices. - 米 The extensive treatment of EPA potable water consists of: - 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}------------------------------------------------ #### ડ. Description of Technological Similarities and Differences The SYSTEM 1E Liquid Chemical Sterilant Processing System is the same as the predicate device except for the specific modification described in this submission. The differences between the proposed and predicate devices are limited to the addition of a new Ultrasound Processing Tray and the Quick Connects that enable the processing of large flexible ultrasound devices and labeling updates to correct errors and provide clarity to users and these proposed changes raise no new concerns of safety and effectiveness when compared to the predicate device. | Feature | Proposed SYSTEM 1E Processor | K161683 SYSTEM 1E Processor | Comparison | |----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities. | The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities. | The minor differences between the Indications for Use for the proposed and predicate devices are for the correction of errors in the Indications for Use, for changes in designation of the pre-filters from 1 and 2 to A and B for consistency with all other labeling and to provide clarity for usage and storage of processed devices. There were no changes in performance. | | | The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6- minute exposure at 45.5 to 60℃, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi- critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use. | The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6- minute exposure at 46 to 55℃, and rinses the load with extensively treated* potable water. The processed load should be used immediately. The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices. * The extensive treatment of EPA potable water consists of: 1. Pre-filtration through two | | | | Proposed | K161683 | | | Feature | SYSTEM 1E Processor | SYSTEM 1E Processor | Comparison | | | The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices. * The extensive treatment of EPA potable water consists of: 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 $\ge$ 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. | pre-filters: • Pre-filter 1 is a gross depth filter that removes approximately 5 micron or larger particles/contaminants. • Pre-filter 2 is a surface filter that removes particles/contaminants > 0.1 micron. 2. UV Irradiation: • During transit through the UV water treatment chamber, a UV dose sufficient to achieve a $\ge$ 6-log reduction of MS2 virus is delivered to the water. 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 | K161683 SYSTEM 1E Processor | Comparison | | Operating Principles/ Technology | A microprocessor controlled unit with interchangeable processing trays/containers. The processor lid opens to reveal the processing chamber in which the load is placed. Devices with internal lumens are interfaced with the processor using connectors. Sterilant Concentrate is placed in a specialized compartment and when the processor fills with water, it creates the sterilant use dilution from the single use sterilant cup. The processor monitors and controls the use dilution temperature and contact time. The processor automatically rinses the load with extensively treated water to remove sterilant residuals. | A microprocessor controlled unit with interchangeable processing trays/containers. The processor lid opens to reveal the processing chamber in which the load is placed. Devices with internal lumens are interfaced with the processor using connectors. Sterilant Concentrate is placed in a specialized compartment and when the processor fills with water, it creates the sterilant use dilution from the single use sterilant cup. The processor monitors and controls the use dilution temperature and contact time. The processor automatically rinses the load with extensively treated water to remove sterilant residuals. | Identical | | Process Parameters | Standardized cycle parameters cannot be altered by operator. The critical process parameters are: Contact Time Use Dilution Temperature Peracetic acid concentration Bacterial retentive water filter integrity UV irradiation | Standardized cycle parameters cannot be altered by operator. The critical process parameters are: Contact Time Use Dilution Temperature Peracetic acid concentration Bacterial retentive water filter integrity UV irradiation | Identical | | Process Monitors | Cycle Printout documents successful cycle completion or identifies fault if cycle aborts Alarms if thermocouples indicate temperature out of specification Alarms if pressure switch indicates that high pressure pump is not operating | Cycle Printout documents successful cycle completion or identifies fault if cycle aborts Alarms if thermocouples indicate temperature out of specification Alarms if pressure switch indicates that high pressure pump is not operating | Identical | | | Proposed | K161683 | | | Feature | SYSTEM 1E Processor | SYSTEM 1E Processor | Comparison | | Design Features | probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification during Diagnostic cycle Alarms if pressure transducer indicates 0.1 micron water filter failed integrity test during liquid chemical sterilant processing and Diagnostic cycles. Alarms if UV monitor indicates UV intensity out of specification Microprocessor controlled unalterable and standardized liquid chemical sterilant processing and Diagnostic cycles Intended for use with S40 Sterilant Concentrate Processor provides dual 0.1 micron filtered, UV treated water for liquid chemical sterilant processing and rinsing Automated dilution and delivery of sterilant Make up air for processor during drain sequences is filtered through a 0.2 micron membrane air filter. | probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification during Diagnostic cycle Alarms if pressure transducer indicates 0.1 micron water filter failed integrity test during liquid chemical sterilant processing and Diagnostic cycles. Alarms if UV monitor indicates UV intensity out of specification Microprocessor controlled unalterable and standardized liquid chemical sterilant processing and Diagnostic cycles Intended for use with S40 Sterilant Concentrate Processor provides dual 0.1 micron filtered, UV treated water for liquid chemical sterilant processing and rinsing Automated dilution and delivery of sterilant Make up air for processor during drain sequences is filtered through a 0.2 micron membrane air filter. | Identical | | Processing Cycle | | | | | Incoming water temperature | $ \u2265 43°C $ | $ \u2265 43°C $ | Identical | | Temperature to start exposure phase | $ \u2265 46°C $ | $ \u2265 46°C $ | Identical | | Feature | Proposed SYSTEM 1E Processor | K161683 SYSTEM 1E Processor | Comparison | | Temperature alarm point during the exposure phase | <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 | Identical | | Rinse water preparation | Hot potable tap water is: • pre-filtered • flowed through a UV Light treatment chamber to achieve ≥ a 6-log reduction of virus • Filtered through redundant 0.1 micron filter membranes | Hot potable tap water is: • pre-filtered • flowed through a UV Light treatment chamber to achieve ≥ a 6-log reduction of virus • Filtered through redundant 0.1 micron filter membranes | Identical | | Number of rinses | 2 | 2 | Identical | | Air Purge | Aids in removing excess water from instrument lumens after rinsing | Aids in removing excess water from instrument lumens after rinsing | Identical | | Water Filter Integrity Test | Conducted at the end of every liquid chemical sterilant processing cycle and during the Diagnostic cycle | Conducted at the end of every liquid chemical sterilant processing cycle and during the Diagnostic cycle | Identical | | Approximate Cycle time | 25 minutes | 25 minutes | Identical | | Feature | Proposed SYSTEM 1E Processor | K161683 SYSTEM 1E Processor | Comparison | | Diagnostic Cycle | Performs 15 tests on processor's systems confirming proper function (same tests as predicate device except for an added UV monitor test). Recommended to perform every 24 hours. After a failed Diagnostic cycle, a liquid chemical sterilant processing cycle cannot be performed until the problem is rectified and a successful Diagnostic cycle has been completed. | Performs 15 tests on processor's systems confirming proper function (same tests as predicate device except for an added UV monitor test). Recommended to perform every 24 hours. After a failed Diagnostic cycle, a liquid chemical sterilant processing cycle cannot be performed until the problem is rectified and a successful Diagnostic cycle has been completed. | Identical | | Interchangeable Components | |…

SYSTEM 1E Liquid Chemical Sterilant Processing System

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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SYSTEM 1E Liquid Chemical Sterilant Processing System

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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