Who is the manufacturer of SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900?

STERIS Corporation filed the 510(k) submission for SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 (K182827).

What is the FDA product code for SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900?

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 1 endo Liquid Chemical Sterilant Processing System, Model 6900?

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

Who can help prepare an FDA 510(k) submission like SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900?

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 1 endo Liquid Chemical Sterilant Processing System, Model 6900

K182827 · STERIS Corporation · MED · Jan 31, 2019 · General Hospital

Device Facts

Record ID	K182827
Device Name	SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900
Applicant	STERIS Corporation
Product Code	MED · General Hospital
Decision Date	Jan 31, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6885
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories in healthcare facilities. The SYSTEM 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.

Device Story

Automated liquid chemical sterilization system; processes cleaned, immersible, semi-critical heat-sensitive medical devices. Input: S40 Sterilant Concentrate (peracetic acid) and water. Operation: Processor automatically dilutes sterilant; maintains 45.5-60°C for 6-minute exposure; performs 2 automated rinses with 0.2-micron filtered water. Model P6900 adds touchscreen interface, barcode scanner, and USB data logging for electronic cycle records. Used in healthcare facilities; operated by staff. Output: Sterilized medical devices; electronic or printed cycle documentation. Benefits: Automated, standardized sterilization process; reduced user exposure to sterilant; electronic record-keeping for facility compliance.

Clinical Evidence

Bench testing only. Performance qualification confirmed cycle parameters (time, temperature, concentration) and diagnostic cycle functionality. Software validation confirmed effective operation. Material compatibility tested through 300 cycles. Sterilant efficacy established via AOAC methods (sporicidal, fungicidal, bactericidal, virucidal, tuberculocidal) and simulated use testing (>6 log10 reduction of Geobacillus stearothermophilus).

Technological Characteristics

Microprocessor-controlled liquid chemical sterilizer. Uses S40 Sterilant Concentrate (35% peracetic acid). Features: touchscreen display, barcode scanner, USB port for data export. Connectivity: optional external printer, web-based data management. Filtration: 0.2-micron bacterial retentive membrane filters for rinse water and air. Standards: UL 61010-1, UL 61010-2-040, IEC 61326-1.

Indications for Use

Indicated for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories 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 1 endo Liquid Chemical Sterilant Processing System, Model P6800 (K173256)

Related Devices

K180342 — SYSTEM 1E Liquid Chemical Sterilant Processing System · Steris Corporations · Apr 4, 2018
K230582 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 · STERIS Corporation · Mar 28, 2023
K131078 — SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM · STERIS Corporation · Jul 5, 2013
K113520 — SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM · STERIS Corporation · Feb 21, 2012
K102462 — SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM · STERIS Corporation · Sep 21, 2010

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). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration". January 31, 2019 STERIS Corporation Marcia Benedict Senior Director, Regulatory Affairs 5976 Heisley Rd Mentor, Ohio 44060 Re: K182827 Trade/Device Name: SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: Class II Product Code: MED Dated: January 7, 2019 Received: January 8, 2019 Dear Marcia Benedict: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmr/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Clarence W. Murray Iii III -S For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K182827 Device Name SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 Indications for Use (Describe) The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critive medical devices and their accessories in healthcare facilities. The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water. The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices. Type of Use (Select one or both, as applicable) | | Prescription Part D or SEP 331 Subsidy Payment | |--|------------------------------------------------| | | Care Transition or SEP 331 Subsidy Start | __ Prescription Use (Part 21 CFR 801 Subpart D) |X | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the STERIS logo. The word STERIS is in large, bold, sans-serif font. Below the word STERIS is an image of several horizontal wavy lines in blue. The lines are stacked on top of each other, creating a visual representation of water or waves. ## 510(k) Summary For SYSTEM 1 endo Liquid Chemical Sterilant Processing System Model P6900 STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198 Contact: Marcia Benedict Senior Director, Regulatory Affairs Tel: 440-392-7063 Fax: 440-357-9198 Submission Date: January 31, 2019 Premarket Notification Number: K182827 STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 {4}------------------------------------------------ #### 1. Device Name | Trade Name: | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | |------------------------|---------------------------------------------------------------------------| | Device Class: | Class 2 | | Common/usual Name: | Liquid Chemical Sterilizer | | Classification Name: | Sterilant, Medical devices, Liquid Chemical Sterilants/Disinfectants | | Classification Number: | 21 CFR 880.6885 | | Product Code: | MED | #### 2. Predicate Device The predicate device is the SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800 cleared under K173256. #### 3. Description of Device The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, cleaned semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo LCS Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. This submission describes modifications to the processor's user interface and controller, to be introduced in Model P6900. The modifications will provide several user convenience features as compared to the originally cleared processor. Model P6800. The advantages for users include an intuitive touchscreen display, a barcode scanner, and the ability to electronically save and download cycle data for facility records. The P6900 model utilizes an updated electronic controller and suitable software, while providing cycles for liquid chemical sterilization (LCS) and system diagnostics identical to those of the original device. The modified SYSTEM 1 endo Processor, which is computer controlled and continually monitored, provides electronic documentation of each cycle. An external printer is available for printed records, if preferred. The SYSTEM 1 endo Processor (whether Model P6800 or P6900) is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in six (6) minutes. After liquid chemical sterilant processing, the liquid chemically sterilized articles are rinsed {5}------------------------------------------------ with 0.2 micron filtered potable water and are ready for use, or may be prepared for storage. The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - peracetic acid - is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials. The interchangeable processing trays/containers are made to accommodate a variety of semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels. Table 1 compares the proposed and predicate devices. #### Indications for Use 4. The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heatsensitive medical devices and their accessories in healthcare facilities. The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water. The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices. #### 5. Technological Characteristics Comparison Table The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is the same as the predicate device except for the specific differences described in this submission, identified in Table 1 below. Table 2 is provided to demonstrate that the S40 Sterilant Concentrate in the modified processor is unchanged. Appropriate changes are made to the processor's software and labeling as a result of the different design features identified. {6}------------------------------------------------ | Feature | Proposed Device SYSTEM 1 endo Processor Model P6900 – K182827 | Predicate Device SYSTEM 1 endo Processor Model P6800 – K173256 | Comparison | |----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use Indications for Use | The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi- critical heat-sensitive medical devices and their accessories in healthcare facilities. The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6- minute exposure at 45.5 to 60°C, and rinses the load with 0.2 micron filtered water. The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices. | The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi- critical heat-sensitive medical devices and their accessories in healthcare facilities. The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6- minute exposure at 45.5 to 60°C, and rinses the load with 0.2 micron filtered water. The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices. | Identical | | | Operating Principles / Technology | A microprocessor controlled unit with interchangeable processing trays/containers. The processor lid opens to reveal the processing chamber in which the load is placed. Devices with internal lumens are interfaced with the processor using connectors, i.e. Quick Connects. S40 Sterilant is placed in a specialized compartment and when the processor fills with water, it creates the sterilant use dilution from the single use sterilant cup. The processor monitors and controls the use dilution temperature and contact time. The processor automatically rinses the load with 0.2 micron filtered water to remove sterilant residuals | A microprocessor controlled unit with interchangeable processing trays/containers. The processor lid opens to reveal the processing chamber in which the load is placed. Devices with internal lumens are interfaced with the processor using connectors, i.e. Quick Connects. S40 Sterilant is placed in a specialized compartment and when the processor fills with water, it creates the sterilant use dilution from the single use sterilant cup. The processor monitors and controls the use dilution temperature and contact time. The processor automatically rinses the load with extensively treated filtered water to remove sterilant residuals. | | Feature | Proposed Device SYSTEM 1 endo Processor Model P6900 – K182827 | Predicate Device SYSTEM 1 endo Processor Model P6800 – K173256 | Comparison | | Process Parameters | Standardized cycle parameters cannot be altered by operator. The critical process parameters are: • Use dilution contact time • Use dilution temperature • Peracetic acid concentration • Integrity of the internal water filter (tested by the system) | Standardized cycle parameters cannot be altered by operator. The critical process parameters are: • Use dilution contact time • Use dilution temperature • Peracetic acid concentration • Integrity of the internal water filter (tested by the system) | Identical | | Process Monitors: | • Electronic and/or printed cycle records document successful cycle completion or identify fault if cycle aborts • Alarms if thermocouples indicate temperature out of specification • Alarms if pressure switch indicates that high pressure pump is not operating • Alarms if conductivity probe indicated conductivity specification not met • Alarms if pressure transducer indicates circulation pressure is out of specification in Diagnostic Cycle • Alarms if pressure transducer indicates internal water filter failed integrity test in Diagnostic Cycle | • Cycle printout documents successful cycle completion or identifies fault if cycle aborts • Alarms if thermocouples indicate temperature out of specification • Alarms if pressure switch indicates that high pressure pump is not operating • Alarms if conductivity probe indicated conductivity specification not met • Alarms if pressure transducer indicates circulation pressure is out of specification in Diagnostic Cycle • Alarms if pressure transducer indicates internal water filter failed integrity test in Diagnostic Cycle | Identical, except cycle records are electronic | | Design Features | • Microprocessor controlled unalterable and standardized liquid chemical sterilization and Diagnostic cycles • Intended for use only with S40 Sterilant Concentrate • Automated dilution and delivery of S40 Sterilant • Processor provides 0.2 micron filtered water for liquid chemical sterilization and rinsing • Make-up air for processor during drain sequences is | • Microprocessor controlled unalterable and standardized liquid chemical sterilization and Diagnostic cycles • Intended for use only with S40 Sterilant Concentrate • Automated dilution and delivery of S40 Sterilant • Processor provides 0.2 micron filtered water for liquid chemical sterilization and rinsing • Make-up air for processor during drain sequences is | The proposed device uses an updated controller and its respective software to provide identical processing parameters. The proposed device uses an updated touchscreen | | Feature | Proposed Device SYSTEM 1 endo Processor Model P6900 – K182827 | Predicate Device SYSTEM 1 endo Processor Model P6800 – K173256 | Comparison | | | filtered through a 0.2 micron membrane air filter Includes a barcode scanner; employs touchscreen display interface; has USB drive for electronic cycle download; facilitates use of a web-based data management system. Separate, optional printer | filtered through a 0.2 micron membrane air filter Has no barcode scanner, employs a membrane touch panel interface and small display, has no USB drive. Includes an onboard printer for cycle information | barcode reader and USB drive for electronic cycle records, and facilitates use of a web-based data mgmt system. Use of printer is optional. | | Cycle Parameters | | | Comparison | | Incoming water temp. | $\geq$ 43°C | $\geq$ 43°C | Identical | | Temperature to start sterilant exposure | $\geq$ 46°C | $\geq$ 46°C | Identical | | Temperature alarm point during LCS exposure | $<$ 45.5 or $>$ 60°C | $<$ 45.5 or $>$ 60°C | Identical | | Temperature range of typical LCS cycle | 46 - 55°C | 46 - 55°C | Identical | | Exposure Time - S40 use dilution | 6 minutes | 6 minutes | Identical | | Rinse water preparation | Hot potable tap water is pre-filtered is filtered through 0.2 micron bacterial retentive membrane filter | Hot potable tap water is pre-filtered is filtered through 0.2 micron bacterial retentive membrane filter | Identical | | Number of rinses | 2 | 2 | Identical | | Air Purge | Aids in removing excess water from instrument lumens after rinsing | Aids in removing excess water from instrument lumens after rinsing | Identical | | Internal Water Filter Integrity Test | Conducted during the Diagnostic cycle | Conducted during the Diagnostic cycle | Identical | | Approximate Cycle Time | 18 - 20 minutes | 18 - 20 minutes | Identical | | Feature | Proposed Device SYSTEM 1 endo Processor Model P6900 – K182827 | Predicate Device SYSTEM 1 endo Processor Model P6800 – K173256 | Comparison | | Diagnostic Cycle | Performs 14 tests on processor's systems confirming proper function. Recommended to perform each day of use. After a failed Diagnostic cycle, a liquid chemical sterilization cycle cannot be performed until the problem is rectified and a successful Diagnostic cycle has been completed. | Performs 14 tests on processor's systems confirming proper function. Recommended to perform each day of use. After a failed Diagnostic cycle, a liquid chemical sterilization cycle cannot be performed until the problem is rectified and a successful Diagnostic cycle has been completed. | Identical | | Accessories | | | | | Sterilant | Uses S40 Sterilant Concentrate – see Table 2 | Uses S40 Sterilant Concentrate – see Table 2 | Identical | | Processing Trays and Containers | Uses interchangeable processing trays/containers • Universal Flex Processing Tray • General Processing Container & Tray • Directed Flow Processing Container & Tray • Flexible Endoscope Processing Container & Tray • Ultrasound Processing Tray | Uses interchangeable processing trays/containers • Universal Flex Processing Tray • General Processing Container & Tray • Directed Flow Processing Container & Tray • Flexible Endoscope Processing Container & Tray • Ultrasound Processing Tray | Identical | | Quick Connects | Uses Quick Connects to attach instrument lumens to the Tray/Container ports | Uses Quick Connects to attach instrument lumens to the Tray/Container ports | Identical | | Chemical Indicator | VERIFY Chemical Indicator for S40 Sterilant is available for use in SYSTEM 1 endo LCSPS | VERIFY Chemical Indicator for S40 Sterilant is available for use in SYSTEM 1 endo LCSPS | Identical | | Spore Test Strip | VERIFY Spore Test Strip for S40 Sterilant for use in SYSTEM 1 endo LCSPS | VERIFY Spore Test Strip for S40 Sterilant for use in SYSTEM 1 endo LCSPS | Identical | | Operator Maintenance | Periodic replacement of water filters and air filter. Periodic replacement of printer tape, if using the external printer option. | Periodic replacement of water filters and air filter. Periodic replacement of printer tape. | Identical, excepting that the printer is an external option | | Feature | S40 Sterilant Concentrate in S1 endo LCSPS Model P6900 – K182827 | S40 Sterilant Concentrate in S1 endo LCSPS Model P6800 - K173256 | Comparison…

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900

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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SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900

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

Section Matches

Product Code Matches

Special Control Matches

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