(143 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, 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 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 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 naso-endoscopes, when used in the enspire 300 AER.
The enspire 300™ Series Automated Endoscope Reprocessor System (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 (HLD).
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 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 assess 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 reduce the risk of 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 STERIS enspire 300 Series Automated Endoscope Reprocessor System underwent several non-clinical studies to demonstrate its safety and effectiveness.
Here is a summary of the acceptance criteria and reported device performance for these studies, along with other requested information where available from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Performance |
|---|---|---|
| Simulated Use Testing - Cleaning | Worst-case devices were soiled and processed in triplicate trials using the cleaning phase of the processing cycle, then examined visually and sampled for quantitation of two soil markers: protein < 6.4 µg/cm² and TOC < 12 µg/cm². | PASS |
| Simulated Use Testing - HLD | Worst case devices were inoculated with Mycobacterium. terrae in triplicate trials and processed using the HLD phase of the processing cycle, then sampled to demonstrate ≥6 log10 reduction per channel of M. terrae. | PASS |
| In Use Testing - Cleaning | Clinically used devices were placed into the enspire 300 AER and exposed to a full processing cycle. At the end of the cycle, the devices were examined visually and sampled for quantitation of two soil markers: protein < 6.4 µg/cm² and TOC < 12 µg/cm². | PASS |
| In Use Testing - HLD | Clinically used devices were placed into the enspire 300 AER and exposed to a full processing cycle. At the end of the cycle, the devices were sampled to demonstrate no growth of organisms. | PASS |
| Rinsing Efficacy (Cytotoxicity test) | A representative endoscope was exposed to multiple processing cycles and extracted per ISO 10993-12:2021. The device extracts were analyzed to verify chemical residual levels were below the highest acceptable levels. | PASS |
| Biocompatibility | A representative endoscope was exposed to multiple processing cycles and extracted per ISO 10993-12: 2021. The device extracts were tested for: Hemolysis per ISO 10993-4:2017 Cytotoxicity per ISO 10993-5:2009/(R) 2014 Sensitization per ISO 10993-10:2021 Acute Systemic toxicity per ISO 10993-11:2017 Irritation per ISO 10993-23:2021 | PASS |
| Toxicological Assessment | The Toxicity assessment of the cleaning and HLD Chemistries for short-term endpoints and the long term/repeated exposure should show no significant risk concerns. | PASS |
| Material Compatibility | Representative devices were exposed to multiple processing cycles and evaluated for physical changes to demonstrate material compatibility with the process and chemistries used. | PASS |
| Human Factors | Typical users were capable of following written instructions for use to correctly load devices into the enspire 300 AER, attach Scope Connectors, and successfully run the processing cycle. | PASS |
| Electrical Safety Conformance | Meets requirements per: UL 61010-1, IEC 61010-2-040:2020, IEC 60601-1-2:2015, +A1:2021 | PASS |
| Software Validation | Meets requirements per: IEC 62304:2006/A1:2016 | PASS |
2. Sample size used for the test set and the data provenance
- Simulated Use Testing: "Worst-case devices" were processed in triplicate trials. The specific number of distinct devices or trials beyond "triplicate" is not specified. The provenance of the data (e.g., country of origin) is not mentioned. This part of the testing is generally conducted in a laboratory setting.
- In Use Testing: "Clinically used devices" were used. The number of such devices is not specified. This implies prospective use in a clinical setting, but further details are not provided.
- Rinsing Efficacy, Biocompatibility, Material Compatibility: "A representative endoscope" or "Representative devices" were exposed to multiple processing cycles. The exact sample size is not specified.
- Human Factors: "Typical users" were observed, but the number of users or specific test cases is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The provided text does not specify the number or qualifications of experts used to establish ground truth for any of the test sets. The determination of "PASS" or "FAIL" is based on meeting the defined technical acceptance criteria (e.g., protein levels, log reduction of bacteria, visual examination) rather than expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method for the test set
The document does not describe an adjudication method (like 2+1, 3+1, or none) for test set results. The results appear to be determined by direct measurement against pre-defined quantitative and qualitative acceptance criteria.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an Automated Endoscope Reprocessor System, not an AI-assisted diagnostic or decision support tool for human readers. "Clinical Testing: Not required for the subject device" is explicitly stated.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The performance detailed in the non-clinical testing for cleaning, high-level disinfection, rinsing efficacy, biocompatibility, toxicological assessment, material compatibility, electrical safety, and software validation represents the standalone performance of the automated endoscope reprocessor system and its associated chemistries. Human factors testing assessed the user's ability to operate the system correctly, which is part of the overall system performance but not "human-in-the-loop" clinical interpretation.
7. The type of ground truth used
The ground truth for the various tests includes:
- Quantitative measurements: Protein levels (< 6.4 µg/cm²), TOC levels (< 12 µg/cm²), log10 reduction of M. terrae (≥ 6 log10), chemical residual levels (below acceptable levels).
- Qualitative observations: Visual examination for cleaning, no growth of organisms after HLD, evaluation for physical changes in material compatibility, proper user operation in human factors.
- Standard conformance: Adherence to specific ISO and IEC standards for biocompatibility, electrical safety, and software validation.
This is primarily based on laboratory and performance testing standards and empirical data.
8. The sample size for the training set
The provided document does not mention a training set. This is because the device is a physical reprocessor system, not a machine learning or AI algorithm that requires a training set for model development.
9. How the ground truth for the training set was established
As no training set is discussed or implied for this type of device, this information is not applicable.
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July 21, 2023
STERIS Corporation Gregory Land Lead Regulatory Affairs Specialist 5960 Heislev Road Mentor, Ohio 44060
Re: K230560
Trade/Device Name: enspire 300 Series Automated Endoscope Reprocessor System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NZA Dated: June 13, 2023 Received: June 13, 2023
Dear Gregory Land:
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
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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,
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
510(k) Number (if known) K230560
Device Name
enspire 300 Series Automated Endoscope Reprocessor System
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, 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 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 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 naso-endoscopes, 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) |
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510(k) Summary enspire 300 Series Automated Endoscope Reprocessor System
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600
Contact: Gregory Land Lead Regulatory Affairs Specialist Tel: 440-392-7424
Summary Date: July 20, 2023
510(k) Number: K230560
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1. Device Name
| Trade Name: | enspire 300 Series Automated EndoscopeReprocessor System |
|---|---|
| Device Classification: | Class II |
| Common/usual Name: | Endoscope Cleaner and Reprocessor |
| Classification Name: | Accessories, Germicide, Cleaning, For Endoscopes |
| Classification Number: | 21 CFR 876.1500 |
| Product Code: | NZA |
2. Predicate Device
Reliance Advance Endoscope Processing System, K123768
3. Description of Device
The enspire 300™ Series Automated Endoscope Reprocessor System (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 (HLD).
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 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 assess 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
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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 reduce the risk of 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.
Indications for Use 4.
The enspire 300 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 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 System 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 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, 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.
న. Technological Characteristic Comparison Tables
| Feature | Proposed enspire 300 SeriesAER | Predicate K123768Reliance Advanced EPS | Comparison |
|---|---|---|---|
| Indicationsfor Use | The enspire 300 AutomatedEndoscope ReprocessorSystem is intended toeffectively provide a pressure | Cleaning and high leveldisinfection of up to twoimmersible, reusable,heat-sensitive, semi- | Similar – bothsystems providecleaning andhigh-level |
| Feature | Proposed enspire 300 Series AER | Predicate K123768 Reliance Advanced EPS | Comparison |
| 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.. | critical devices such as GI flexible endoscopes, bronchoscopes and their accessories.During the system's standardized Endoscope Processing Cycle, cleaning is achieved within the Cleaning phase, and high level disinfection is achieved within the 50 – 57°C HLD phase (4 minute generation sequence followed by a 6-minute exposure sequence).Manual cleaning is not required prior to processing in Reliance EPS version 2. | disinfection | |
| The enspire 300 Automated Endoscope Reprocessor System 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 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, reusable, semi critical heat sensitive | |||
| Feature | Proposed enspire 300 SeriesAER | Predicate K123768Reliance Advanced EPS | Comparison |
| medical devices including, butnot limited to, flexibleendoscopes and non-channelednaso-endoscopes, when used inthe enspire 300 AER. | |||
| 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 tohelp prevent contamination ofthe Reprocessor during periodof inactivity. Descaling Cycleis used to help prevent andremove scale build-up in theReprocessor. | The Reliance EPS and itsintegrated endoscopeprocessing supportprovide for delivery ofsolutions and fluids toendoscopes and theiraccessories. Klenzymeand Reliance DG areintroduced into theReliance EPS to providecleaning and high leveldisinfection.Decontamination cycles(D-Long with CIP-200and D-Short) are used toprevent biofilm formationin the Reliance EPSProcessor and ensureeffective processingfollowing periods ofprocessor inactivity | Similar - thesubject deviceand thepredicate deviceboth useenzymaticcleaner andperacetic acidfor cleaning andhigh leveldisinfection,respectively.The disinfectiondiffers betweenthe two, thesubject deviceuses thermaldisinfectionwhile thepredicate useschemical. |
| ProcessParameters | The cycle parameters cannotbe altered by operator. Thecritical process parameters are:• Contact Time• Use Dilution Temp• Water Volume• Chemical Volume• Channel irrigationflow/pressure | Standardized cycleparameters cannot bealtered by operator. Thecritical processparameters are:• Contact Time• Use Dilution Temp• Cleaning solution andReliance DGconcentration• Water filter integrity | Similar- thesubject deviceuses water andchemicalvolume ratherthan solutionconcentration.The subjectdevice alsoprovides flowmonitoring |
| ProcessMonitors | Channel irrigation flow alarmswhen endoscope channel isobstructed or disconnected, ifpressure too low or too high,or if sensor defect is detected.Chemical volume alarms ifchemical injected volume is | Control Handle Bootpressure alarms ifpressure too low toprocess, or if too high andcould potentially damagescopes (specification 6.5to 10.5 PSI) | Similar - theproposed devicehas additionalprocessmonitoring ofall endoscopelumens |
| Feature | Proposed enspire 300 SeriesAER | Predicate K123768Reliance Advanced EPS | Comparison |
| too high, too low, chemicalpump is defective or chemicalcontainer has inadequatevolume to complete the cycle.Water volume alarms whenwater level is too high forHLD.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. | Detection of a freshReliance DG container inevery processing cycle,Cleaning Solution levelmonitored; alarmindicates when containerdoes not have sufficientamount to complete cycleTemperature alarms ifoutside of rangeWater filter integrity testat end of each high leveldisinfection cycle. | individually. | |
| DesignFeatures | Intended for use with Revital-Ox 2X Concentrate EnzymaticDetergent and Revital-OxPAA HLD Microprocessor controlled Internal componentsconstructed of stainless steel,silicone, polypropylene andPVDF. Processor provides 0.2 micronfiltered water for rinsing Automated injection ofcleaning and HLD solutions,with accuracy monitored by aflow meter Uses dried, oil free and filteredcompressed air for Air Purge Automated endoscope pressuremonitor Monitors channel flow Includes a bar code scanner;employs touchscreen displayinterface Separate, optional printer | Intended for use withReliance DG only Microprocessorcontrolled Internal componentsconstructed of stainlesssteel, silicone,polypropylene andPVDF. Processor provides 0.2micron filtered water forwashing, disinfection andrinsing Automated injection ofsolutions with accuracymonitored by a flowmeter. Automated generationand delivery of high leveldisinfectant solution Air intake for Air Purgeis HEPA filtered Automated endoscopeleak test Barcode scanner Separate, optional printer | Similar – thesubject devicehas additionalmonitoring ofchannel flowand use of atouch screen. |
| Cycle Parameters | |||
| PressureMonitor | Performed at the beginning ofthe cycle | Performed at thebeginning of the cycle | Same |
| Flow check | Performed at the beginningand end of the cycle | Not present | Different – Thesubject devicehas a Flow |
| Feature | Proposed enspire 300 SeriesAER | Predicate K123768Reliance Advanced EPS | Comparison |
| CleaningPhaseTemperature | 50-55°C | 50-57°C | Check in thecycle whichmonitors theflow to eachlumen of anendoscope |
| CleaningPhaseExposure time | 4.5 minutes wash | 5 minutes | Similar –subject device isquicker |
| Rinse phaseafter cleaning | 30 seconds | 40 seconds | Similar –subject device isquicker |
| HLD phaseTemperature | 50-55°C | 50-57°C | Similar –subject deviceoperates in anarrower rangeof the predicaterange |
| HLD phaseexposure time | 3 minutes | 6 minutes | Similar –subject device isquicker |
| Rinse Phaseafter HLDphase | 30 seconds | 40 seconds | Similar –subject device isquicker |
| Number ofrinses | 2 | 2 | Same |
| Air purge | Performed between each phaseand at the end of the cycle | Performed at the end ofthe cycle | Same |
| Accessories | Comparison | ||
| Detergent | Revital-Ox 2X ConcentrateEnzymatic Detergent | Klenzyme | Similar – bothare enzymaticcleaners |
| HLD | Revital-Ox PAA HLD | Reliance DG | Similar – bothare peraceticacid based HLD |
| ChemicalIndicator | enspire 300 series AERProcess monitor. Peraceticacid dose indicator for routinemonitoring of enspire 300AER using Revital-Ox PAA | VERIFY ProcessIndicator for RelianceEPS. Peracetic acid doseindicator for routinemonitoring of Reliance | Similar – bothuse a chemicalindicator but theindicator isdifferent |
| Feature | Proposed enspire 300 SeriesAER | Predicate K123768Reliance Advanced EPS | Comparison |
| HLD. Chemical reaction onindicator pad to produce colorchange. | EPS using Reliance DG.Chemical reaction onindicator pad to producecolor change. | ||
| ScopeConnectors /Flow Units | Scope connectors are requiredfor all lumens of endoscopes. | Flow Units are requiredonly for scope channelsthat do not open in theendoscope control handleor mechanical action isrequired for valveoperation. | Similar – bothuse connectorsto flush lumensof endoscopes |
| OperatorMaintenance | Periodic replacement of waterfilters. Periodic replacementof printer tape if using theexternal printer option.Running the decontaminationcycle every 24 hours. | Periodic replacement ofwater and air filters. D-SHORT decontaminationcycle required every 54-hoursD-LONGdecontamination cyclerequired if D-SHORT notperformed within past 54hours | Similar – bothrequire theperiodicreplacement offilters andrunning ofdecontaminationcycles. |
Table 1. Predicate Device Comparison Table
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Table 2. HLD Device Comparison Table
| Feature | Proposed Revital-Ox PAAHLD | Predicate Reliance DGDry Germicide | Comparison |
|---|---|---|---|
| Intended Use | The Revital-Ox PA HighLevel Disinfectant (HLD) is atwo-part solution, whichwhen mixed, is intended toprovide high leveldisinfection of validatedimmersible, reusable, semi-critical, heat sensitivemedical devices including,but not limited to, flexibleendoscopes and non-channeled naso-endoscopes,when used in the enspire 300AER. | The Reliance EndoscopeProcessing System isintended for washing andhigh level disinfection ofup to two manually pre-cleaned, immersible,reusable, heat-sensitive,semi-critical devices suchas GI flexible endoscopes,bronchoscopes and theiraccessories. High leveldisinfection is achievedwithin the 50-57°C HLDphase of the endoscopeprocessing cycle (4-minute generationsequence followed by a 6-minute exposuresequence). | Same |
| Germicidal | High level disinfectant | High level disinfectant | Same |
| Feature | Proposed Revital-Ox PAAHLD | Predicate Reliance DGDry Germicide | Comparison |
| claimGermicideExposure timefor HLD (min) | 3 minutes | 10 minutes (4-minutegeneration sequencefollowed by a 6-minuteexposure sequence) | Similar – Theexposure timefor high leveldisinfection isquicker on thesubject device |
| UseTemperature | 50-55°C | 50-57°C | Similar – theoperating rangeis narrower andincluded in thepredicate device |
| Reuse | Single Use dilution | Single Use dilution | Same |
| ActiveIngredient | Peracetic acid | Peracetic acid | Same |
| Mode ofAction | It is believed that peraceticacid exerts its germicidaleffect by severalmechanisms:-oxidizing sulfhydral andsulfur bonds in proteins andenzymes, particularly in thecell walls1-hydroxyl radicals producedfrom PAA are bactericidal2-PAA damages the viralcapsid and viral nucleicacid3,4 | It is believed thatperacetic acid exerts itsgermicidal effect byseveral mechanisms: | Same |
| Rinse | 2 rinses, 30 seconds eachwith 0.2µ filtered water | 2 rinses, 40 seconds each,with 0.2µ filtered water | Similar – therinse time of thesubject device isquicker |
| Microbial EfficacySporicidalActivity ofDisinfectantsAOACOfficialMethod966.04 | Meets efficacy requirements.Bacillus subtilisClostridium sporogenes | Meets efficacyrequirements.Bacillus subtilisClostridium sporogenes | Same |
| ConfirmatorySporicidalActivity ofDisinfectants | Meets efficacy requirements.5Bacillus subtilisClostridium sporogene | Meets efficacyrequirements.5Bacillus subtilisClostridium sporogenes | Same |
| Feature | Proposed Revital-Ox PAAHLD | Predicate Reliance DGDry Germicide | Comparison |
| AOACOfficialMethod966.04 | |||
| FungicidalActivity ofDisinfectantsAOACOfficialMethod955.17 | Solution is fungicidal.Trichophyton interdigitale | Solution is fungicidal.Trichophytonmentagrophytes | Same |
| Use-DilutionMethodAOAC,OfficialMethods955.14,955.15, 964.02 | Solution is bactericidalSalmonella entericaStaphylococcus aureusPseudomonas aeruginosa | Solution is bactericidal.Salmonella choleraesuisStaphylococcus aureusPseudomonas aeruginosa | Same |
| EPA VirucidalTesting(DIS/TSS-7,Nov. 1981) | Process conditions arevirucidal.Herpes simplex Type 1Adenovirus Type 5Poliovirus Type 1 | Process conditions arevirucidal.Herpes simplex Type 1Adenovirus Type 5Poliovirus Type 1 | Same |
| TuberculocidalActivityAscenziQuantitativeSuspensionTest | Solution is tuberculocidalMycobacterium terrae | Solution is tuberculocidalMycobacterium terrae | Same |
| Simulated UseTest | Meets efficacy requirement.≥ 6 log reductionMycobacterium terrae in amanual application | Meets efficacyrequirement. ≥ 6 logreduction Mycobacteriumterrae in a manualapplication | Same |
| Clinical In-usetest | Non survivingmicroorganisms onrepresentative medicaldevices tested | Non survivingmicroorganisms onrepresentative medicaldevices tested | Same |
| Bio compatibility | |||
| Cytotoxicitydevice extracts | Non-Cytotoxic per ISO10993-5 | Non-cytotoxic per ISO10993-5 | Same |
| ResidueReduction | Automatic within the enspire300 AER. 2 rinses with 0.2µfiltered water after HLDcycle effectively reduces | Automatic within theReliance EndoscopeProcessor, 2 rinses with0.2µ filtered water after | Same |
| Feature | Proposed Revital-Ox PAAHLD | Predicate Reliance DGDry Germicide | Comparison |
| germicide residues to safelevels. | HLD cycle effectivelyreduces residuesgermicide residues to safelevels. | ||
| DeviceMaterialCompatibility | Compatible with medicaldevices as established bytesting finished flexibleendoscopes through 300cycles and rigid devicesthrough 150 cycles.No functional changes haveoccurred to flexible or rigiddevices.Some materials showcosmetic changes such asfading of black anodizedaluminum without harm tothe base material. | Compatible with intendedflexible endoscopes andaccessories establishedthrough testing finishedmedical devices. Nodevice functional changes.Some materials showcosmetic changes such asfading of externalmarkings but all remainedlegible and fading of blackanodized aluminumwithout harm to the basematerial. | Same |
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6. Summary of Non-Clinical Testing
Shown in Table 3 is the new testing that was performed to evaluate the enspire 300 Automated Endoscope Reprocessor System.
| Table 3. Summary of verification activities. | ||
|---|---|---|
| -- | ---------------------------------------------- | -- |
| Test | Acceptance Criteria | Result |
|---|---|---|
| Simulated UseTesting | Cleaning: Worst-case devices were soiled and processed intriplicate trials using the cleaning phase of the processing cycle,then examined visually and sampled for quantitation of two soilmarkers: protein < 6.4 µg/cm² and TOC < 12 µg/cm². | PASS |
| High Level Disinfection: Worst case devices were inoculated withMycobacterium. terrae in triplicate trials and processed using theHLD phase of the processing cycle, then sampled to demonstrate≥6 log10 reduction per channel of M. terrae. | PASS | |
| In Use Testing | Cleaning: Clinically used devices were placed into the enspire 300AER and exposed to a full processing cycle. At the end of thecycle, the devices were examined visually and sampled forquantitation of two soil markers: protein < 6.4 µg/cm² and TOC < 12 µg/cm². | PASS |
| High Level Disinfection: Clinically used devices were placed intothe enspire 300 AER and exposed to a full processing cycle. At theend of the cycle, the devices were sampled to demonstrate nogrowth of organisms. | PASS | |
| Rinsing Efficacy(Cytotoxicity) | A representative endoscope was exposed to multiple processingcycles and extracted per ISO 10993-12:2021. The device extracts | PASS |
| Test | Acceptance Criteria | Result |
| test) | were analyzed to verify chemical residual levels were below the highest acceptable levels. | |
| Biocompatibility | A representative endoscope was exposed to multiple processing cycles and extracted per ISO 10993-12: 2021. The device extracts were tested for Hemolysis per ISO 10993-4:2017 Cytotoxicity per ISO 10993-5:2009/(R) 2014 Sensitization per ISO 10993-10:2021 Acute Systemic toxicity per ISO 10993-11:2017 Irritation per ISO 10993-23:2021 | PASS |
| Toxicological Assessment | The Toxicity assessment of the cleaning and HLD Chemistries for short-term endpoints and the long term/repeated exposure should show no significant risk concerns. | PASS |
| Material Compatibility | Representative devices were exposed to multiple processing cycles and evaluated for physical changes to demonstrate material compatibility with the process and chemistries used. | PASS |
| Human Factors | Typical users were capable of following written instructions for use to correctly load devices into the enspire 300 AER, attach Scope Connectors, and successfully run the processing cycle. . | PASS |
| Electrical Safety Conformance | Meets requirements per: UL 61010-1, Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use – Part 1: General Requirements, 3rd Edition IEC 61010-2-040:2020, Safety Requirements for Electrical Equipment for measurement, control and laboratory use – Part 2-040: Particular Requirements for Sterilizers and Washer-Disinfectors Used to Treat Medical Materials IEC 60601-1-2:2015, +A1:2021 Medical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. | PASS |
| Software Validation | Meets requirements per: IEC 62304:2006/A1:2016, Medical device software – Software life cycle processes [Including Amendment 1(2016)] | PASS |
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Clinical Testing: Not required for the subject device
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 (K123768), 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.