(14 days)
The enspire™ 300 Series Automated Endoscope Reprocessor System is intended to effectively provide a pressure and channel monitor, clean, high-level disinfect, rinse and air purge validated immersible, reusable, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes. The validated cleaning process replaces manual cleaning for endoscopes other than duodenoscopes. Manual Cleaning of endoscopes is required prior to placement in high level disinfection only cycle.
The enspire 300 Series Automated Endoscope Reprocessor System uses Revital-Ox PAA High Level Disinfectant to provide high level disinfection of validated immersible, reusable, semi-critical, heat sensitive medical devices. It automatically mixes the Part B solutions, high level disinfects the load during a controlled cycle and rinses the load. The wash phase of the enspire 300 Series Automated Endoscope Reprocessor System cycle uses only Revital-Ox 2X Concentrate Enzymatic Detergent to perform cleaning.
The Revital-Ox PA High Level Disinfectant (HLD) is a two-part solution, which when mixed, is intended to provide high level disinfection of validated immersible, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled nasoendoscopes, when used in the enspire 300 AER.
The enspire 300™ Series Automated Endoscope Reprocessor (AER) is a medical device processing system used for cleaning and high level disinfection of immersible, reusable, semi-critical, heat-sensitive devices such as flexible endoscopes and their accessories. The system consists of the enspire 300 AER. Revital-Ox 2X Concentrate Enzymatic Detergent (R2X), and Revital-Ox Peracetic Acid High Level Disinfectant.
The enspire 300 series AER is an automated, self-contained device for the effective cleaning and high level disinfection of semi-critical medical devices and their accessories. Prior to placement in the processor, users will be instructed to perform bedside (point of use) cleaning and manual leak testing. The devices will not require manual pre-cleaning prior to processing, with the exception of duodenoscopes which will still require manual cleaning per the manufacturer's written instructions. Channel Connectors, as identified in STERIS labeling, are used to facilitate the delivery of the R2X detergent, HLD solution and rinse water to internal channels of devices that have them.
On the first process of an endoscope, the user must create a scope profile for the endoscope in the AER. The creation of the scope profile saves key endoscope attributes to the AER which are used to monitor the cycle during processing of the device. Once the device is positioned in the enspire 300 AER and optional operator ID, case ID, procedure ID and physician information is inputted, the operator initiates the processing cycle during which the Processor will create and maintain the conditions necessary for effective cleaning and high level disinfection. At the beginning of the processing cycle, an automated pressure monitor is performed to confirm the integrity of the flexible endoscope. In parallel with the pressure monitor and prior to initiation of the cleaning phase, the processing system will evaluate the flow coefficient of each individual channel and compare to their respective reference value stored in the device profile created prior to first processing. The enspire 300 AER maintains inflation of the processed device throughout the process to prevent ingress of fluid in the event of any loss of integrity. At the end of the processing cycle, the cleaned and high level disinfected devices are rinsed with 0.2 micron filtered potable water followed by a dried, oil free, filtered compressed air purge to evacuate rinse water from the endoscope channels. The AER, which is micro-processor controlled and continually monitored, provides documentation of each cycle.
The enspire 300 AER utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and Revital-Ox Peracetic Acid High Level Disinfectant for high level disinfection. Revital-Ox PAA HLD is a two part solution consisting of Part A, 15% PAA, and Part B, conditioner.
The document discusses an Automated Endoscope Reprocessor (AER) and its comparison to a predicate device, focusing on non-clinical testing. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance testing with replacement pre-filters | The modification does not affect the performance of the device. | Pass |
Note: This table is directly extracted from the provided text. The "modified device" refers to the enspire 300 Series AER with new support material for its pre-filters.
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size used for the performance testing with replacement pre-filters. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature). The testing is described as "new testing" performed to evaluate the modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The testing described is performance testing of a medical device, which typically involves engineering and microbiology evaluations, not expert review for ground truth in the way it might be for an AI model interpreting medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiologists interpreting images) to establish a consensus ground truth. This document describes performance testing of an automated reprocessing device, which doesn't involve such human interpretive adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable as the device is an Automated Endoscope Reprocessor, not an AI-assisted diagnostic or interpretive system. Therefore, no MRMC study or effect size related to human readers improving with AI assistance would have been conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a "standalone" automated system for reprocessing endoscopes. The described "Performance testing with replacement pre-filters" evaluates the device's functional performance in this automated capacity. There isn't an "algorithm only" aspect in the sense of a software-based diagnostic tool, but rather the overall automated operation of the mechanical and chemical processes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the "Performance testing with replacement pre-filters," the ground truth implicitly refers to the established performance requirements for an Automated Endoscope Reprocessor (e.g., effective cleaning and high-level disinfection, proper fluid delivery, temperature control, etc., as detailed in the "Description of Device" and "Process Monitors" sections). The acceptance criterion "The modification does not affect the performance of the device" implies that the device's ability to meet these established functional and safety parameters, which would be verified through specific engineering and potentially microbiological tests, serves as the ground truth. It's not a ground truth derived from expert consensus on interpretations or patient outcomes data directly from this specific test.
8. The sample size for the training set:
This information is not applicable. The device is a physical medical device (Automated Endoscope Reprocessor), not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable since there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 3, 2023
Steris Corporation Nalepka Jennifer Manager, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060
Re: K232918
Trade/Device Name: enspire 300 Series Automated Endoscope Reprocessor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NZA Dated: September 19, 2023 Received: September 19, 2023
Dear Nalepka Jennifer:
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.
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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.
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 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).
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Sincerely,
Bifeng Qian -S
Bifeng Qian, M.D., 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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
enspire 300 Series Automated Endoscope Reprocessor
Indications for Use (Describe)
The enspire™ 300 Series Automated Endoscope Reprocessor System is intended to effectively provide a pressure and channel monitor, clean, high-level disinfect, rinse and air purge validated immersible, reusable, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes. The validated cleaning process replaces manual cleaning for endoscopes other than duodenoscopes. Manual Cleaning of endoscopes is required prior to placement in high level disinfection only cycle.
The enspire 300 Series Automated Endoscope Reprocessor System uses Revital-Ox PAA High Level Disinfectant to provide high level disinfection of validated immersible, reusable, semi-critical, heat sensitive medical devices. It automatically mixes the Part B solutions, high level disinfects the load during a controlled cycle and rinses the load. The wash phase of the enspire 300 Series Automated Endoscope Reprocessor System cycle uses only Revital-Ox 2X Concentrate Enzymatic Detergent to perform cleaning.
The Revital-Ox PA High Level Disinfectant (HLD) is a two-part solution, which when mixed, is intended to provide high level disinfection of validated immersible, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled nasoendoscopes, when used in the enspire 300 AER.
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.
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Image /page/4/Picture/1 description: The image shows the logo for STERIS. The word "STERIS" is written in a bold, sans-serif font. Below the word is an image of several horizontal, wavy lines stacked on top of each other. The lines are blue.
510(k) Summary K232918 enspire 300 Series Automated Endoscope Reprocessor
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600
Contact: Jennifer Nalepka Manager, Regulatory Affairs Tel: 440-392-7458
Summary Date: October 2, 2023
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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Device Name 1.
Trade Name:
Device Classification: Common/usual Name: Classification Name: Classification Number: Product Code:
enspire 300 Series Automated Endoscope Reprocessor Class II Endoscope Cleaner and Reprocessor Accessories, Germicide, Cleaning, For Endoscopes 21 CFR 876.1500 NZA
2. Predicate Device
enspire 300 Series Automated Endoscope Reprocessor, K230560
Description of Device 3.
The enspire 300™ Series Automated Endoscope Reprocessor (AER) is a medical device processing system used for cleaning and high level disinfection of immersible, reusable, semi-critical, heat-sensitive devices such as flexible endoscopes and their accessories. The system consists of the enspire 300 AER. Revital-Ox 2X Concentrate Enzymatic Detergent (R2X), and Revital-Ox Peracetic Acid High Level Disinfectant.
The enspire 300 series AER is an automated, self-contained device for the effective cleaning and high level disinfection of semi-critical medical devices and their accessories. Prior to placement in the processor, users will be instructed to perform bedside (point of use) cleaning and manual leak testing. The devices will not require manual pre-cleaning prior to processing, with the exception of duodenoscopes which will still require manual cleaning per the manufacturer's written instructions. Channel Connectors, as identified in STERIS labeling, are used to facilitate the delivery of the R2X detergent, HLD solution and rinse water to internal channels of devices that have them.
On the first process of an endoscope, the user must create a scope profile for the endoscope in the AER. The creation of the scope profile saves key endoscope attributes to the AER which are used to monitor the cycle during processing of the device. Once the device is positioned in the enspire 300 AER and optional operator ID, case ID, procedure ID and physician information is inputted, the operator initiates the processing cycle during which the Processor will create and maintain the conditions necessary for effective cleaning and high level disinfection. At the beginning of the processing cycle, an automated pressure monitor is performed to confirm the integrity of the flexible endoscope. In parallel with the pressure monitor and prior to initiation of the cleaning phase, the processing system will evaluate the flow coefficient of each individual channel and compare to their respective reference value stored in the device profile created prior to first processing. The enspire 300 AER maintains inflation of the processed device throughout the process to prevent ingress of fluid in the event of any loss of integrity. At the end of the processing cycle, the cleaned and high level disinfected devices are rinsed with 0.2 micron filtered potable water followed by a dried, oil free, filtered compressed air purge to evacuate rinse water from the endoscope channels. The AER, which is micro-processor controlled and continually monitored, provides documentation of each cycle.
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The enspire 300 AER utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and Revital-Ox Peracetic Acid High Level Disinfectant for high level disinfection. Revital-Ox PAA HLD is a two part solution consisting of Part A, 15% PAA, and Part B, conditioner.
4. Indications for Use
The enspire 300 Automated Endoscope Reprocessor is intended to effectively provide a pressure and channel monitor, clean, high-level disinfect, rinse and air purge validated immersible, reusable, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled nasoendoscopes. The validated cleaning process replaces manual cleaning for endoscopes other than duodenoscopes. Manual Cleaning of endoscopes is required prior to placement in high level disinfection only cycle.
The enspire 300 Automated Endoscope Reprocessor uses Revital-Ox PA High Level Disinfectant to provide high level disinfection of validated immersible, reusable, semi-critical, heat sensitive medical devices. It automatically mixes the Part A and Part B solutions; high level disinfects the load during a controlled cycle and rinses the load. The wash phase of the enspire 300 Series Automated Endoscope Reprocessor cycle uses only Revital-Ox 2X Concentrate Enzymatic Detergent to perform cleaning.
The Revital-Ox PA High Level Disinfectant (HLD) is a two-part solution, which when mixed, is intended to provide high level disinfection of validated immersible, reusable, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes, when used in the enspire 300 AER.
Technological Characteristic Comparison Tables ട്.
| Feature | Proposedenspire 300 Series AER | Predicateenspire 300 Series AER(K230560) | Comparison |
|---|---|---|---|
| Indications forUse | The enspire 300 AutomatedEndoscope Reprocessor isintended to effectively provide apressure and channel monitor,clean, high-level disinfect, rinseand air purge validatedimmersible, reusable, semi-critical, heat sensitive medicaldevices including, but notlimited to, flexible endoscopesand non-channeled naso-endoscopes. The validatedcleaning process replacesmanual cleaning for endoscopesother than duodenoscopes. | The enspire 300 AutomatedEndoscope Reprocessor isintended to effectively provide apressure and channel monitor,clean, high-level disinfect, rinseand air purge validatedimmersible, reusable, semi-critical, heat sensitive medicaldevices including, but notlimited to, flexible endoscopesand non-channeled naso-endoscopes. The validatedcleaning process replacesmanual cleaning for endoscopesother than duodenoscopes. | Identical |
| Feature | Proposedenspire 300 Series AER | Predicateenspire 300 Series AER(K230560) | Comparison |
| Manual Cleaning of endoscopesis required prior to placement inhigh level disinfection onlycycle. | Manual Cleaning of endoscopesis required prior to placement inhigh level disinfection onlycycle. | ||
| The enspire 300 AutomatedEndoscope Reprocessor usesRevital-Ox PA High LevelDisinfectant to provide highlevel disinfection of validatedimmersible, reusable, semi-critical, heat sensitive medicaldevices. It automatically mixesthe Part A and Part B solutions;high level disinfects the loadduring a controlled cycle andrinses the load. The wash phaseof the enspire 300 SeriesAutomated EndoscopeReprocessor cycle uses onlyRevital-Ox 2X ConcentrateEnzymatic Detergent to performcleaning. | The enspire 300 AutomatedEndoscope Reprocessor usesRevital-Ox PA High LevelDisinfectant to provide highlevel disinfection of validatedimmersible, reusable, semi-critical, heat sensitive medicaldevices. It automatically mixesthe Part A and Part B solutions;high level disinfects the loadduring a controlled cycle andrinses the load. The wash phaseof the enspire 300 SeriesAutomated EndoscopeReprocessor cycle uses onlyRevital-Ox 2X ConcentrateEnzymatic Detergent to performcleaning. | ||
| OperatingPrinciples /Technology | The enspire 300 AER providedelivery of solutions and fluidsto endoscopes and theiraccessories. Revital-Ox 2XConcentrate Enzymaticdetergent and Revital-Ox PAAHLD are introduced into theenspire 300 AER to providecleaning and high leveldisinfection. Decontaminationcycle is used to help withroutine maintenance and to helpprevent contamination of theReprocessor during period ofinactivity. Descaling Cycle isused to help prevent and removescale build-up in theReprocessor. | The enspire 300 AER providedelivery of solutions and fluidsto endoscopes and theiraccessories. Revital-Ox 2XConcentrate Enzymaticdetergent and Revital-Ox PAAHLD are introduced into theenspire 300 AER to providecleaning and high leveldisinfection. Decontaminationcycle is used to help withroutine maintenance and to helpprevent contamination of theReprocessor during period ofinactivity. Descaling Cycle isused to help prevent and removescale build-up in theReprocessor. | Identical |
| ProcessParameters | The cycle parameters cannot bealtered by operator. The criticalprocess parameters are:● Contact Time● Use Dilution Temp● Water Volume● Chemical Volume | The cycle parameters cannot bealtered by operator. The criticalprocess parameters are:● Contact Time● Use Dilution Temp● Water Volume● Chemical Volume | Identical |
| Feature | Proposedenspire 300 Series AER | Predicateenspire 300 Series AER(K230560) | Comparison |
| • Channel irrigationflow/pressure | • Channel irrigationflow/pressure | ||
| ProcessMonitors | Channel irrigation flow alarmswhen endoscope channel isobstructed or disconnected, ifpressure too low or too high, orif sensor defect is detected.Chemical volume alarms ifchemical injected volume is toohigh, too low, chemical pump isdefective or chemical containerhas inadequate volume tocomplete the cycle. Watervolume alarms when water levelis too high for HLD.Temperature alarm is triggeredwhen temperature is too high,sump takes too long to heat,RTD variance exceeded or asensor is defective. Alarm istriggered if Real Time Clockerror is detected. | Channel irrigation flow alarmswhen endoscope channel isobstructed or disconnected, ifpressure too low or too high, orif sensor defect is detected.Chemical volume alarms ifchemical injected volume is toohigh, too low, chemical pump isdefective or chemical containerhas inadequate volume tocomplete the cycle. Watervolume alarms when water levelis too high for HLD.Temperature alarm is triggeredwhen temperature is too high,sump takes too long to heat,RTD variance exceeded or asensor is defective. Alarm istriggered if Real Time Clockerror is detected. | Identical |
| DesignFeatures | • Intended for use withRevital-Ox 2X ConcentrateEnzymatic Detergent andRevital-Ox PAA HLD• Microprocessor controlled• Internal componentsconstructed of stainless steel,silicone, polypropylene andPVDF.• Processor provides pre-filtered water and theproposed filters have a newsupport material.• 0.2 micron filtered waterused for rinsing• Automated injection ofcleaning and HLD solutions,with accuracy monitored by aflow meter• Uses dried, oil free andfiltered compressed air forAir Purge• Automated endoscopePressure monitor• Monitors channel flow | • Intended for use withRevital-Ox 2X ConcentrateEnzymatic Detergent andRevital-Ox PAA HLD• Microprocessor controlled• Internal componentsconstructed of stainless steel,silicone, polypropylene andPVDF.• Processor provides pre-filtered water• 0.2 micron filtered waterused for rinsing• Automated injection ofcleaning and HLD solutions,with accuracy monitored by aflow meter• Uses dried, oil free andfiltered compressed air forAir Purge• Automated endoscopePressure monitor• Monitors channel flow• Includes a bar code scanner;employs touchscreen displayinterface | Similar - functionandbiocompatibility ofpre-filter isunchanged. |
| Feature | Proposedenspire 300 Series AER | Predicateenspire 300 Series AER(K230560) | Comparison |
| Includes a bar code scanner; employs touchscreen display interface Separate, optional printer | Separate, optional printer | ||
| Cycle Parameters | Comparison | ||
| PressureMonitor | Performed at the beginning ofthe cycle | Performed at the beginning ofthe cycle | Identical |
| Flow check | Performed at the beginning andend of the cycle | Performed at the beginning andend of the cycle | Identical |
| CleaningPhaseTemperature | 50-55°C | 50-55°C | Identical |
| CleaningPhaseExposure time | 4.5 minutes wash | 4.5 minutes wash | Identical |
| Rinse phaseafter cleaning | 30 seconds | 30 seconds | Identical |
| HLD phaseTemperature | 50-55°C | 50-55°C | Identical |
| HLD phaseexposure time | 3 minutes | 3 minutes | Identical |
| Rinse Phaseafter HLDphase | 30 seconds | 30 seconds | Identical |
| Number ofrinses | 2 | 2 | Identical |
| Air purge | Performed between each phaseand at the end of the cycle | Performed between each phaseand at the end of the cycle | Identical |
| Accessories | Comparison | ||
| Detergent | Revital-Ox 2X ConcentrateEnzymatic Detergent | Revital-Ox 2X ConcentrateEnzymatic Detergent | Identical |
| HLD | Revital-Ox PAA HLD | Revital-Ox PAA HLD | Identical |
| ChemicalIndicator | enspire 300 series AER Processmonitor. Peracetic acid doseindicator for routine monitoringof enspire 300 AER usingRevital-Ox PAA HLD.Chemical reaction on indicatorpad to produce color change. | enspire 300 series AER Processmonitor. Peracetic acid doseindicator for routine monitoringof enspire 300 AER usingRevital-Ox PAA HLD.Chemical reaction on indicatorpad to produce color change. | Identical |
| ScopeConnectors /Flow Units | Scope connectors are requiredfor all lumens of endoscopes. | Scope connectors are requiredfor all lumens of endoscopes. | Identical |
| OperatorMaintenance | Periodic replacement of waterfilters. Periodic replacement ofprinter tape if using the externalprinter option. Running thedecontamination cycle every 24hours. | Periodic replacement of waterfilters. Periodic replacement ofprinter tape if using the externalprinter option. Running thedecontamination cycle every 24hours. | Identical |
Table 1. Predicate Device Comparison Table
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STERIS Traditional 510(k) PREMARKET NOTIFICATION enspire 300 Series Automated Endoscope Reprocessor
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STERIS Traditional 510(k) PREMARKET NOTIFICATION enspire 300 Series Automated Endoscope Reprocessor
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STERIS Traditional 510(k) PREMARKET NOTIFICATION enspire 300 Series Automated Endoscope Reprocessor
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6. Summary of Non-Clinical Testing
Shown in Table 2 is the new testing that was performed to evaluate the modified device.
| Verification Activity | Description |
|---|---|
| ----------------------- | ------------- |
| Test | Acceptance Criteria | Result |
|---|---|---|
| Performance testing withreplacement pre-filters | The modification does not affect theperformance of the device. | Pass |
7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device (K230560), Class II (21 CFR 876.1500), product code NZA.
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.