← Product Code [FEB](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FEB) · K243433 # enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (K243433) _STERIS Corporation · FEB · Dec 2, 2024 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-b%E2%80%94diagnostic-devices/FEB/K243433 ## Device Facts - **Applicant:** STERIS Corporation - **Product Code:** [FEB](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FEB.md) - **Decision Date:** Dec 2, 2024 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Intended Use The enspire™ 3000 Series Cleaning and Liquid Chemical Sterilant Processing System is intended to effectively provide a pressure monitor, clean, provide liquid chemical sterilization, rinse, and air purge validated immersible, reusable, semicritical, heat sensitive medical devices such as flexible endoscopes and their accessories. The validated cleaning process replaces cleaning for endoscopes other than duodenoscopes. Manual cleaning of duodenoscopes according to the manufacturer's written instructions for use is required prior to placement in the enspire™ 3000 Series Processor. The enspire™ 3000 Series Processor uses only Revital-Ox 2X Concentrate Enzymatic detergent to clean and S40 Sterilant Concentrate to liquid chemically sterilize medical devices. It automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liguid chemically sterilizes the load during a controlled 6-minute exposure at 46.6 to 55°C and rinses the load with 0.2-micron filtered water. ## Device Story Automated, self-contained processing system for flexible endoscopes; performs pressure monitoring, cleaning, liquid chemical sterilization, rinsing, and air purging. Inputs: endoscopes, Revital-Ox 2X Enzymatic Detergent, S40 Sterilant Concentrate. Operation: automated dilution of sterilant; 6-minute exposure at 46.6-55°C; 0.2-micron filtered water rinse; HEPA-filtered air purge. Pressure monitoring performed at cycle start/end to ensure integrity. Used in clinical settings; operated by healthcare personnel. Output: processed, sterilized endoscopes; electronic cycle documentation. Benefits: standardized, validated reprocessing; reduced manual labor; automated leak detection; ensures device integrity and sterility. ## Clinical Evidence Bench testing only. Testing included chemical delivery reproducibility, material compatibility (tensile testing), rinsing efficacy (chemical residual analysis per ISO 10993-12), and biocompatibility (cytotoxicity per ISO 10993-5). All tests passed. ## Technological Characteristics Automated, microprocessor-controlled system. Chemical Delivery System (CDS) components (cup receiver, lid) constructed of polysulfone (PS). Uses peracetic acid-based S40 Sterilant Concentrate and enzymatic detergent. Features: rotating spray arm, 0.2-micron water filtration, HEPA air filtration, pressure monitoring, barcode scanner, touchscreen interface, USB data export. Standardized, unalterable cycle parameters. ## Regulatory Identification An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. ## Special Controls *Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9. ## Predicate Devices - enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System ([K230930](/device/K230930.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 2, 2024 STERIS Corporation Jennifer Nalepka Manager, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060 Re: K243433 Trade/Device Name: enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FEB Dated: November 5, 2024 Received: November 5, 2024 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 (the 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 available 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory {2}------------------------------------------------ assistance/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, # Katharine Segars -S Katharine Segars, Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use Submission Number (if known) K243433 Device Name enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System Indications for Use (Describe) The enspire™ 3000 Series Cleaning and Liquid Chemical Sterilant Processing System is intended to effectively provide a pressure monitor, clean, provide liquid chemical sterilization, rinse, and air purge validated immersible, reusable, semicritical, heat sensitive medical devices such as flexible endoscopes and their accessories. The validated cleaning process replaces cleaning for endoscopes other than duodenoscopes. Manual cleaning of duodenoscopes according to the manufacturer's written instructions for use is required prior to placement in the enspire™ 3000 Series Processor. The enspire™ 3000 Series Processor uses only Revital-Ox 2X Concentrate Enzymatic detergent to clean and S40 Sterilant Concentrate to liquid chemically sterilize medical devices. It automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liguid chemically sterilizes the load during a controlled 6-minute exposure at 46.6 to 55°C and rinses the load with 0.2-micron filtered water. 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." {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the STERIS logo. The word "STERIS" is in large, bold, sans-serif font at the top of the image. Below the word is a graphic of several horizontal wavy lines in blue, resembling water waves. # 510(k) Summary enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System K243433 STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Contact: Jennifer Nalepka Manager, Regulatory Affairs Tel: 440-392-7458 Email: jennifer_nalepka@steris.com November 27, 2024 Summary Date: STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 {5}------------------------------------------------ #### 1. Device Name | Trade Name: | enspire 3000 Cleaning and Liquid Chemical Sterilant
Processing System | |------------------------|--------------------------------------------------------------------------| | Device Classification: | Class II | | Common/usual Name: | Endoscope Cleaner and Reprocessor | | Classification Name: | Endoscope and Accessories | | Classification Number: | 21 CFR 876.1500 | | Product Code: | FEB | #### 2. Predicate Device enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System, K230930 #### 3. Description of Device The enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (CLCSPS) is a medical device processing system used for cleaning and liquid chemically sterilizing immersible, reusable, semi-critical, heat-sensitive devices such as flexible endoscopes and their accessories. The system consists of the enspire 3000 Processor, Revital-Ox 2X Concentrate Enzymatic Detergent, S40 Sterilant Concentrate and Max Flow Connectors. The enspire 3000 Cleaning and LCSPS is an automated, self-contained device for the effective cleaning and liquid chemical sterilization of semi-critical medical devices and their accessories. The devices will not require manual cleaning prior to processing in the enspire 3000 Processor with the exception of duodenoscopes which must be manually cleaned per the manufacturer's instructions for use. In addition, prior to placement in the enspire 3000 processor, the device will undergo a manual leak test and the user will ensure the lumens are not blocked. If the device has internal channels or lumens, Max Flow Connectors are used to facilitate the delivery of detergent, sterilant use-solution and rinse water to internal channels. Once the device is positioned in the enspire 3000 processor, the unit will create and maintain the conditions necessary for effective cleaning and liquid chemical sterilization of the load. At the beginning of the processing cycle, automated pressure monitoring is performed to confirm the integrity of the flexible endoscope throughout the process. The enspire 3000 processor maintains inflation of the processed device to prevent ingress of fluid during processing and the pressure monitoring is repeated at the end of the processing cycle to ensure that the device is leak tight after cleaning and liquid chemical sterilization. At the end of the processing cycle, the cleaned and liquid chemically sterilized devices are rinsed with 0.2 micron filtered potable water followed by a HEPA-filtered air purge to aid in drying the endoscope. The processor, which is computer controlled and continually monitored, provides documentation of each cvcle. The enspire 3000 processor utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and S40 Sterilant Concentrate for liquid chemical sterilization. S40 Sterilant {6}------------------------------------------------ Concentrate is a single use chemical sterilant concentrate; its active ingredient, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials. ### Proposed Modification The modification being proposed for clearance through this premarket notification is for a change in materials of the Chemical Delivery System (CDS) of the enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System (CLCSPS). The CDS is designed to hold the S40 Sterilant Concentrate cup and puncture the start of the liquid chemical sterilization phase of the cycle so that the chemistry can be mixed with water to form the use dilution. The CDS assembly consists of a cup receiver and lid, puncture needle, pneumatic cylinder, and door. The cup receiver and lid are made from acrylonitrile butadiene styrene (ABS) plastic and these parts will be changed to be made from polysulfone (PS). #### 4. Indications for Use The enspire™ 3000 Series Cleaning and Liquid Chemical Sterilant Processing System is intended to effectively provide a pressure monitor, clean, provide liquid chemical sterilization, rinse, and air purge validated immersible, reusable, semi-critical, heat sensitive medical devices such as flexible endoscopes and their accessories. The validated cleaning process replaces cleaning for endoscopes other than duodenoscopes. Manual cleaning of duodenoscopes according to the manufacturer's written instructions for use is required prior to placement in the enspire™ 3000 Series Processor. The enspire™ 3000 Series Processor uses only Revital-Ox 2X Concentrate Enzymatic detergent to clean and S40 Sterilant Concentrate to liquid chemically sterilize medical devices. It 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 46.6 to 55°C and rinses the load with 0.2-micron filtered water. ### ട. Technological Characteristic Comparison Tables {7}------------------------------------------------ | Table 1. Predicate Device Comparison Table | | | | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Feature | Proposed Device
K243433
enspire 3000 Cleaning and
Liquid Chemical Sterilant
Processing System (CLCSPS) | Predicate Device
K230930
enspire 3000 Cleaning and
Liquid Chemical Sterilant
Processing System (CLCSPS) | Comparison | | Intended Use
Indications for
Use | The enspire™ 3000 Series
Cleaning and Liquid Chemical
Sterilant Processing System is
intended to effectively provide a
pressure monitor, clean, provide
liquid chemical sterilization, rinse,
and air purge validated
immersible, reusable, semi-critical,
heat sensitive medical devices
such as flexible endoscopes and
their accessories.

The validated cleaning process
replaces cleaning for endoscopes
other than duodenoscopes. Manual
cleaning of duodenoscopes
according to the manufacturer's
written instructions for use is
required prior to placement in the | The enspire™ 3000 Series
Cleaning and Liquid Chemical
Sterilant Processing System is
intended to effectively provide a
pressure monitor, clean, provide
liquid chemical sterilization, rinse,
and air purge validated
immersible, reusable, semi-critical,
heat sensitive medical devices
such as flexible endoscopes and
their accessories.

The validated cleaning process
replaces cleaning for endoscopes
other than duodenoscopes. Manual
cleaning of duodenoscopes
according to the manufacturer's
written instructions for use is
required prior to placement in the | Identical | | Feature | Proposed Device
K243433
enspire 3000 Cleaning and
Liquid Chemical Sterilant
Processing System (CLCSPS)
enspire™ 3000 Series Processor. | Predicate Device
K230930
enspire 3000 Cleaning and
Liquid Chemical Sterilant
Processing System (CLCSPS)
enspire™ 3000 Series Processor. | Comparison | | Operating
Principles /
Technology | The enspire™ 3000 Series
Processor uses only Revital-Ox 2X
Concentrate Enzymatic detergent
to clean and S40 Sterilant
Concentrate to liquid chemically
sterilize medical devices. It
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
46.6 to 55°C and rinses the load
with 0.2-micron filtered water.
Microprocessor controlled unit
with a fixed basin. The processor lid is opened
with hands-free lid operation. Devices with internal lumens
are interfaced with the
processor using connectors,
i.e. Max Flow Units Instrument pressure
monitoring performed at
beginning and end of cycle to
monitor endoscope integrity Revital-Ox 2X Concentrate
Enzymatic Detergent is
dispensed for the cleaning
phase of the processing cycle. Single-use cup of S40
Sterilant Concentrate is placed
in a specialized compartment;
when the processor fills with
water during the LCS phase of
the processing cycle, it creates
the sterilant use dilution The processor automatically
rinses the load with 0.2 micron
filtered water after cleaning
and LCS phases HEPA-filtered air purge to aid
in drying | The enspire™ 3000 Series
Processor uses only Revital-Ox 2X
Concentrate Enzymatic detergent
to clean and S40 Sterilant
Concentrate to liquid chemically
sterilize medical devices. It
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
46.6 to 55°C and rinses the load
with 0.2-micron filtered water.
Microprocessor controlled unit
with a fixed basin. The processor lid is opened
with hands-free lid operation. Devices with internal lumens
are interfaced with the
processor using connectors,
i.e. Max Flow Units Instrument pressure
monitoring performed at
beginning and end of cycle to
monitor endoscope integrity Revital-Ox 2X Concentrate
Enzymatic Detergent is
dispensed for the cleaning
phase of the processing cycle. Single-use cup of S40
Sterilant Concentrate is placed
in a specialized compartment;
when the processor fills with
water during the LCS phase of
the processing cycle, it creates
the sterilant use dilution The processor automatically
rinses the load with 0.2 micron
filtered water after cleaning
and LCS phases HEPA-filtered air purge to aid
in drying | Identical | | Feature | Proposed Device
K243433
enspire 3000 Cleaning and
Liquid Chemical Sterilant
Processing System (CLCSPS) | Predicate Device
K230930
enspire 3000 Cleaning and
Liquid Chemical Sterilant
Processing System (CLCSPS) | Comparison | | Process
Parameters | Standardized cycle parameters
cannot be altered by the operator.
The critical process parameters
monitored during processing:
Detergent dilution and
cleaning timeDetergent dilution temperatureUse dilution contact timeUse dilution temperature | Standardized cycle parameters
cannot be altered by the operator.
The critical process parameters
monitored during processing:
Detergent dilution and
cleaning timeDetergent dilution temperatureUse dilution contact timeUse dilution temperature | Identical | | Process
Monitors | The processor monitors and
controls the detergent and LCS
use dilution phase times.Cycle record documents
successful cycle completion or
identifies fault if cycle abortsAlarms if RTDs indicate
temperature out of
specificationAlarms if pressure switch
indicates that high pressure
pump is not operatingAlarms if pressure transducer
indicates circulation pressure is
out of specificationAlarms if internal water filter
failed Filter Integrity Test.Alarms if loss of pressure
inside of endoscope indicates a
leak | The processor monitors and
controls the detergent and LCS
use dilution phase times.Cycle record documents
successful cycle completion or
identifies fault if cycle abortsAlarms if RTDs indicate
temperature out of
specificationAlarms if pressure switch
indicates that high pressure
pump is not operatingAlarms if pressure transducer
indicates circulation pressure is
out of specificationAlarms if internal water filter
failed Filter Integrity Test.Alarms if loss of pressure
inside of endoscope indicates a
leak | Identical | | Design
Features | Unalterable and standardized
Processing Cycle for cleaning
and liquid chemical
sterilizationFilter Integrity Test for
demonstrating 0.2 micron
water filter maintains
functionality after replacement
or power outageAutomated stand-alone system
with one reprocessing basinBasin lid features a rotating
spray arm.Intended for use with only
Revital-Ox 2X Concentrate | Unalterable and standardized
Processing Cycle for cleaning
and liquid chemical
sterilizationFilter Integrity Test for
demonstrating 0.2 micron
water filter maintains
functionality after replacement
or power outageAutomated stand-alone system
with one reprocessing basinBasin lid features a rotating
spray arm.Intended for use with only
Revital-Ox 2X Concentrate | Identical | | Feature | Proposed Device
K243433
enspire 3000 Cleaning and
Liquid Chemical Sterilant
Processing System (CLCSPS) | Predicate Device
K230930
enspire 3000 Cleaning and
Liquid Chemical Sterilant
Processing System (CLCSPS) | Comparison | | | Sterilant Concentrate
• Automated delivery of
Revital-Ox 2X Concentrate
Enzymatic Detergent
• Automated dilution and
delivery of S40 Sterilant
• Processor provides 0.2 micron
filtered water for liquid
chemical sterilization and
rinsing after LCS phase of
Processing Cycle
• Compressed air for processor
during drain sequence is
filtered through a 0.2 micron
membrane air filter
• Includes a bar code scanner;
employs touchscreen display
interface; has USB drive for
electronic cycle download;
facilitates use of a web-based
data management system.
• Separate, optional printer | Sterilant Concentrate
• Automated delivery of
Revital-Ox 2X Concentrate
Enzymatic Detergent
• Automated dilution and
delivery of S40 Sterilant
• Processor provides 0.2 micron
filtered water for liquid
chemical sterilization and
rinsing after LCS phase of
Processing Cycle
• Compressed air for processor
during drain sequence is
filtered through a 0.2 micron
membrane air filter
• Includes a bar code 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 | | Comparison | | Integrity Test | Performed at beginning and end of
cycle | Performed at beginning and end of
cycle | Identical | | Pre-Rinse
Phase | Pre-filtered water at 40°C | Pre-filtered water at 40°C | Identical | | Incoming
Water Temp | 37 - 45°C | 37 - 45°C | Identical | | Cleaning
Phase
Temperature | > 42.2°C | > 42.2°C | Identical | | Cleaning
Phase
Exposure
Time | 2 minutes | 2 minutes | Identical | | Rinse Phase
after Cleaning | Pre-filtered water below 55°C | Pre-filtered water below 55°C | Identical | | HLD or LCS
Phase
Temperature
Range | LCS: 46.6 - 50°C | LCS: 46.6 - 50°C | Identical | | HLD or LCS
Phase
Exposure | 6 minutes | 6 minutes | Identical | | Feature | Proposed Device
K243433
enspire 3000 Cleaning and
Liquid Chemical Sterilant
Processing System (CLCSPS) | Predicate Device
K230930
enspire 3000 Cleaning and
Liquid Chemical Sterilant
Processing System (CLCSPS) | Comparison | | Time | | | | | Rinse Phase
after HLD or
LCS | Hot potable tap water that is pre-
filtered then filtered through a 0.2
micron bacterial retentive filter | Hot potable tap water that is pre-
filtered then filtered through a 0.2
micron bacterial retentive filter | Identical | | Number of
rinses | 2 after Cleaning Phase
2 after LCS Phase… --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-b%E2%80%94diagnostic-devices/FEB/K243433](https://fda.innolitics.com/submissions/HO/subpart-b%E2%80%94diagnostic-devices/FEB/K243433) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com