Who is the manufacturer of SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900?

STERIS Corporation filed the 510(k) submission for SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (K230582).

What is the regulatory pathway for SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900?

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

Who can help prepare an FDA 510(k) submission like SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900?

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 P6900

Q: What is the FDA product code for SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900?

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

K230582 · STERIS Corporation · MED · Mar 28, 2023 · General Hospital

Device Facts

Record ID	K230582
Device Name	SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
Applicant	STERIS Corporation
Product Code	MED · General Hospital
Decision Date	Mar 28, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 880.6885
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable sensitive medical devices and their accessories in healthcare facilities. The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water. The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

Device Story

Automated liquid chemical sterilization system for heat-sensitive medical devices; uses S40 Sterilant Concentrate (peracetic acid). Processor dilutes sterilant, maintains 45.5-60°C for 6-minute exposure, and performs two rinses with 0.2-micron filtered water. Used in healthcare facilities; operated by staff. Features interchangeable trays/containers and Quick Connects for internal channels. Microprocessor-controlled; includes barcode scanner, touchscreen, and USB for data management. Monitors critical parameters (time, temperature, concentration, filter integrity) and provides alarms/cycle printouts. Benefits include effective sterilization of heat-sensitive instruments while limiting user exposure to sterilant.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via non-clinical testing of new control boards and software confirmation tests, ensuring proper cycle operation and alarm functionality.

Technological Characteristics

Microprocessor-controlled unit; uses S40 Sterilant Concentrate (35% peracetic acid). Features: interchangeable processing trays/containers, Quick Connects, 0.2-micron water/air filters, barcode scanner, touchscreen, USB data port. Sterilization cycle: 6-minute exposure at 45.5-60°C. Rinse: 2 cycles with 0.2-micron filtered water. Software: microprocessor-controlled, unalterable standardized cycles.

Indications for Use

Indicated for liquid chemical sterilization of cleaned, immersible, reusable semi-critical heat-sensitive medical devices and 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 P6900 (K222615)

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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. March 28, 2023 STERIS Corporation Jennifer Nalepka Manager, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060 Re: K230582 Trade/Device Name: SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 Regulation Number: 21 CFR 880.6885 Regulation Name: Sterilant, Medical Devices, Liquid Chemical Sterilants/Disinfectants Regulatory Class: Class II Product Code: MED Dated: March 1, 2023 Received: March 2, 2023 Dear Jennifer Nalepka: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Clarence W. Murray III -S Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use #### 510(k) Number (if known) K230582 Device Name SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 Indications for Use (Describe) The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable sensitive medical devices and their accessories in healthcare facilities. The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water. The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices. | Type of Use (Select one or both, as applicable) | |------------------------------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) | 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, black font at the top of the image. Below the word is a graphic of several horizontal blue lines that are curved to resemble waves. # 510(k) Summary For SYSTEM 1 endo Liquid Chemical Sterilant Processing System Model P6900 K230582 STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Contact: Jennifer Nalepka Manager, Regulatory Affairs Phone: (440) 392-7458 Email: jennifer nalepka@steris.com March 1, 2023 Summary Date: STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 {4}------------------------------------------------ #### 1. Device Name | Trade Name: | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | |------------------------|---------------------------------------------------------------------------| | Device Class: | Class II | | Common/Usual Name: | Liquid Chemical Sterilizer | | Classification Name: | Sterilant, Medical Devices, Liquid Chemical Sterilants/Disinfectants | | Classification Number: | 21 CFR 880.6885 | | Product Code: | MED | #### 2. Predicate Device SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, K222615 #### 3. Description of Device The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (S1 endo) is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The S1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. After LCS processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage. The S1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials. The interchangeable processing trays/containers are made to accommodate a variety of semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific S1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels. Tables 1 and 2 compare the proposed and predicate devices. #### 4. Indications for Use The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories in healthcare facilities. The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water. {5}------------------------------------------------ The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices. ## 5. Technical Characteristic Comparison Table The S1 endo is the same as the predicate device with the exception of the proposed modification. A comparison between the proposed and predicate devices can be found in Table 1 and Table 2 below. | Feature | Proposed Device SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | Predicate Device SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (K222615) | Comparison | |------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Intended Use Indications for Use | The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi- critical heat-sensitive medical devices and their accessories in healthcare facilities. The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6- minute exposure at 45.5 to 60°C, and rinses the load with 0.2 micron filtered water. The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices. | The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi- critical heat-sensitive medical devices and their accessories in healthcare facilities. The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6- minute exposure at 45.5 to 60°C, and rinses the load with 0.2 micron filtered water. The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices. | Identical | | Operating Principles / Technology | A microprocessor controlled unit with interchangeable processing trays/containers. The processor lid opens to reveal the processing chamber in which the load is placed. Devices with internal lumens are interfaced with the processor using connectors, i.e. Quick Connects | A microprocessor controlled unit with interchangeable processing trays/containers. The processor lid opens to reveal the processing chamber in which the load is placed. Devices with internal lumens are interfaced with the processor using connectors, i.e. Quick Connects. | Identical | | Feature | Proposed Device SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | Predicate Device SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (K222615) | Comparison | | | S40 Sterilant is placed in a specialized compartment and when the processor fills with water, it creates the sterilant use dilution from the single use sterilant cup. The processor monitors and controls the use dilution temperature and contact time. The processor automatically rinses the load with 0.2 micron filtered water to remove sterilant residuals. | S40 Sterilant is placed in a specialized compartment and when the processor fills with water, it creates the sterilant use dilution from the single use sterilant cup. The processor monitors and controls the use dilution temperature and contact time. The processor automatically rinses the load with 0.2 micron filtered water to remove sterilant residuals. | | | Process Parameters | Standardized cycle parameters cannot be altered by operator. The critical process parameters are: Use dilution contact time Use dilution temperature Peracetic acid concentration Integrity of the internal water filter (tested by the system) | Standardized cycle parameters cannot be altered by operator. The critical process parameters are: Use dilution contact time Use dilution temperature Peracetic acid concentration Integrity of the internal water filter (tested by the system) | Identical | | Process Monitors: | Cycle Printout documents successful cycle completion or identifies fault if cycle aborts Alarms if thermocouples indicate temperature out of specification Alarms if pressure switch indicates that high pressure pump is not operating Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification in Diagnostic cycle Alarms if pressure transducer indicates internal water filter failed integrity test | Cycle Printout documents successful cycle completion or identifies fault if cycle aborts Alarms if thermocouples indicate temperature out of specification Alarms if pressure switch indicates that high pressure pump is not operating Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification in Diagnostic cycle Alarms if pressure transducer indicates internal water filter failed integrity test | Identical | | Design Features | Microprocessor controlled unalterable and standardized | Microprocessor controlled unalterable and standardized | Identical | | Feature | Proposed Device SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | Predicate Device SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (K222615) | Comparison | | | liquid chemical sterilization and Diagnostic cycles Intended for use only with S40 Sterilant Concentrate Automated dilution and delivery of S40 Sterilant Processor provides 0.2 micron filtered water for liquid chemical sterilization and rinsing Make-up air for processor during drain sequences is filtered through a 0.2 micron membrane air filter Includes a barcode scanner; employs touchscreen display interface; has USB drive for electronic cycle download; facilitates use of a web-based data management system. Separate, optional printer | liquid chemical sterilization and Diagnostic cycles Intended for use only with S40 Sterilant Concentrate Automated dilution and delivery of S40 Sterilant Processor provides 0.2 micron filtered water for liquid chemical sterilization and rinsing Make-up air for processor during drain sequences is filtered through a 0.2 micron membrane air filter Includes a barcode scanner; employs touchscreen display interface; has USB drive for electronic cycle download; facilitates use of a web-based data management system. Separate, optional printer | | | Cycle Parameters | | | | | Incoming water temp. | $\geq 43°C$ | $\geq 43°C$ | Identical | | Temperature to start sterilant exposure | $\geq 46°C$ | $\geq 46°C$ | Identical | | Temperature alarm point during LCS exposure | $< 45.5$ 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 | | Feature | Proposed Device SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | Predicate Device SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (K222615) | Comparison | | Number of rinses | 2 | 2 | Identical | | Air Purge | Aids in removing excess water from instrument lumens after rinsing | Aids in removing excess water from instrument lumens after rinsing | Identical | | Internal Water Filter Integrity Test | Conducted during the Diagnostic cycle | Conducted during the Diagnostic cycle | Identical | | Approximate Cycle Time | 18 - 20 minutes | 18 - 20 minutes | Identical | | Diagnostic Cycle | Performs 14 tests on processor's systems confirming proper function. Recommended to perform each day of use. After a failed Diagnostic cycle, a liquid chemical sterilization cycle cannot be performed until the problem is rectified and a successful Diagnostic cycle has been completed. | Performs 14 tests on processor's systems confirming proper function. Recommended to perform each day of use. After a failed Diagnostic cycle, a liquid chemical sterilization cycle cannot be performed until the problem is rectified and a successful Diagnostic cycle has been completed. | Identical | | Accessories | | | | | Sterilant | Uses S40 Sterilant Concentrate | Uses S40 Sterilant Concentrate | Identical | | Processing Trays and Containers | Uses interchangeable processing trays/containers • Universal Flex Processing Tray • General Processing Container & Tray • Directed Flow Processing Container & Tray • Flexible Endoscope Processing Container & Tray • Ultrasound Processing Tray | Uses interchangeable processing trays/containers • Universal Flex Processing Tray • General Processing Container & Tray • Directed Flow Processing Container & Tray • Flexible Endoscope Processing Container & Tray • Ultrasound Processing Tray | Identical | | Quick Connects | Uses Quick Connects to attach instrument lumens to the Tray/Container ports | Uses Quick Connects to attach instrument lumens to the Tray/Container ports | Identical | | Chemical Indicator | VERIFY Chemical Indicator for S40 Sterilant is available for use in SYSTEM 1 endo LCSPS | VERIFY Chemical Indicator for S40 Sterilant is available for use in SYSTEM 1 endo LCSPS | Identical | | Spore Test Strip | VERIFY Spore Test Strip for S40 Sterilant for use in SYSTEM 1 endo LCSPS | VERIFY Spore Test Strip for S40 Sterilant for use in SYSTEM 1 endo LCSPS | Identical | | Feature | Proposed Device SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | Predicate Device SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (K222615) | Comparison | | Operator Maintenance | Periodic replacement of water filters and air filter. Periodic replacement of printer tape, if using the external printer option. | Periodic replacement of water filters and air filter. Periodic replacement of printer tape, if using the external printer option. | Identical | Table 1. Processor Comparison Table. {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ | Table 2. S40 Sterilant Concentrate Comparison Table | | | |-----------------------------------------------------|--|--| | | | | | Feature | Proposed Device S40 Sterilant Concentrate | Predicate Device S40 Sterilant Concentrate (K222615) | Comparison | |-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Indications for Use | The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices. | The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices. | Identical | | Germicidal claim | Liquid Chemical Sterilant | Liquid Chemical Sterilant | Identical | | Germicide Exposure Time (min) for intended use | 6 | 6 | Identical | | Use Temperature | 45.5-60°C – allowable 46-55°C - typical Potency and simulated use evaluations conducted at <43°C | 45.5-60°C – allowable 46-55°C - typical Potency and simulated use evaluations conducted at <43°C | Identical | | Reuse | Single use | Single use | Identical | | Human Factors | Dispensed ready to use. Container is opened and diluted by the processor, thus limiting user exposure to the active ingredient | Dispensed ready to use Container is opened and diluted by the processor, thus limiting user exposure to the active ingredient | Identical | | Active Ingredient | 35% peroxyacetic (peracetic) acid automatically diluted for use in the SYSTEM 1E Processor. | 35% peroxyacetic (peracetic) acid automatically diluted for use in the SYSTEM 1E Processor. | Identical | | Mode of Action | It is believed that peracetic acid exerts its germicidal effect by several mechanisms: -oxidizing sulfhydryl and sulfur bonds in proteins and enzymes, particularly in the cell walls 1 -hydroxyl radicals produced from PAA are bactericidal 2 | It is believed that peracetic acid exerts its germicidal effect by several mechanisms: -oxidizing sulfhydryl and sulfur bonds in proteins and enzymes, particularly in the cell walls1 -hydroxyl radicals produced from PAA are bactericidal2 | Identical | | Feature | Proposed Device S40 Sterilant Concentrate | Predicate Device S40 Sterilant Concentrate (K222615) | Comparison | | Rinses | -PAA damages the viral capsid and viral nucleic acid3,4. | -PAA damages the viral capsid and viral nucleic acid3,4 | Identical | | | Automatic, UV-irradiated, dual 0.1 micron filtered, potable hot water. | Automatic, UV-irradiated, dual 0.1 micron filtered, potable hot water. | | | Microbial Efficacy | | | | | Sporicidal Activity of Disinfectants AOAC Official Method 966.04 | Meets efficacy requirements5. Bacillus subtilis Clostridium sporogenes Testing conducted in vitro | Meets efficacy requirements5. Bacillus subtilis Clostridium sporogenes Testing conducted in vitro | Identical | | Confirmatory Sporicidal Activity of Disinfectants AOAC Official Method 966.04 | Meets efficacy requirements6. Bacillus subtilis Clostridium sporogenes Testing conducted in vitro | Meets efficacy requirements6. Bacillus subtilis Clostridium sporogenes Testing conducted in vitro | Identical | | Fungicidal Activity of Disinfectants AOAC Official Method 955.17 | Solution is fungicidal. Trichophyton mentagrophytes Testing conducted in vitro | Solution is fungicidal. Trichophyton mentagrophytes Testing conducted in vitro | Identical | | Use Dilution Method AOAC, Official Methods 955.14, 955.15, 964.02 | Solution is bactericidal. Salmonella choleraesuis Staphylococcus aureus Pseudomonas aeruginosa Testing conducted in vitro | Solution is bactericidal. Salmonella choleraesuis Staphylococcus aureus Pseudomonas aeruginosa | Identical | | EPA Viricidal Testing (DIS/TSS-7, Nov. 1981) | Solution is viricidal. Herpes simplex Type 1 Adenovirus Type 5 Poliovirus Type 1 Testing conducted in vitro | Solution is viricidal. Herpes simplex Type 1 Adenovirus Type 5 Poliovirus Type 1 Testing conducted in vitro | Identical | | Tuberculocidal Activity Ascenzi Quantitative Suspension Test | Solution is tuberculocidal Mycobacterium terrae Testing conducted in vitro | Solution is tuberculocidal Mycobacterium terrae Testing conducted in vitro | Identical | | Feature | Proposed Device S40 Sterilant Concentrate | Predicate Device S40 Sterilant Concentrate (K222615) | Comparison | | Simulated-Use Test | Meets efficacy requirement. $\geq$ 6 log reduction Geobacillus stearothermophilus spores in a manual application | Meets efficacy requirement. $\geq$ 6 log reduction Geobacillus stearothermophilus spores in a manual application | Identical | | Clinical In- Use | No surviving microorganisms on representative medical devices tested | No surviving microorganisms on representative medical devices tested | Identical | | Biocompatibility | | | | | Cytotoxicity Device Extracts | Two rinses with UV treated, dual 0.1-micron membrane filtered water effectively reduce sterilant residues to safe levels. | Two rinses with UV treated, dual 0.1-micron membrane filtered water effectively reduce sterilant residues to safe levels. | Identical | | Residue Reduction | Automatic within the SYSTEM 1E Processor: Two rinses with UV treated, dual 0.1-micron membrane filtered water effectively reduce sterilant residues to safe levels. | Automatic within the SYSTEM 1E Processor: Two rinses with UV treated, dual 0.1-micron membrane filtered water effectively reduce sterilant residues to safe levels. | Identical | | Device Material Compatibility | Compatible with medical devices as established by testing finished flexible endoscopes through 300 cycles and rigid devices through 150 cycles. No functional changes have occurred to flexible devices. Some materials show cosmetic changes such as fading of black anodized aluminum without harm to the base material. | Compatible with medical devices as established by testing finished flexible endoscopes through 300 cycles and rigid devices through 150 cycles. No functional changes have occurred to flexible devices. Some materials show cosmetic changes such as fading of black anodized aluminum without harm to the base material. | Identical | 1 Block, S. ed., Disinfection, Sterilization, and Preservation. 5th edition, 2001. 2 Clapp et al., Free Rad. Res., (1994) 21:147-167. ² Clapp et al., Free Rad. Res., (1994) 21:147-167. {10}------------------------------------------------ ³ Maillard et. al., J. Med. Mi…

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

Device Facts

Indications for Use

Device Story

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Technological Characteristics

Indications for Use

Regulatory Classification

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SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

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Indications for Use

Device Story

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Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

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