(88 days)
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, 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 medically 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.
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 assess the integrity of the flexible endoscope throughout the process. The enspire 3000 processor maintains inflation of the processed device to reduce the risk of ingress of fluid during processing and the pressure monitoring is repeated at the end of the processing cycle. 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 cycle.
The enspire 3000 processor utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and S40 Sterilant Concentrate for liquid chemical sterilization. S40 Sterilant 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.
The document describes the enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use Testing - Cleaning | Worst-case devices were soiled and processed in triplicate using the cleaning phase, 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 - LCS | Worst-case devices were inoculated with Geobacillus stearothermophilus in triplicate trials and processed using the LCS phase, then sampled to demonstrate no growth of organisms. | PASS |
| Simulated Use Testing - Duodenoscopes | Worst-case devices were inoculated with Geobacillus stearothermophilus in triplicate trials and processed using an abbreviated LCS phase (2.5-minute), then sampled to demonstrate no growth of organisms. | PASS |
| In Use Testing - Cleaning | Clinically used devices were placed into the enspire 3000 processor 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 - Liquid Chemical Sterilization | Clinically used devices were placed into the enspire 3000 processor 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 | A representative endoscope was exposed to multiple processing cycles and extracted per ISO 10993-12. The device extracts were analyzed to verify chemical residual levels were below the highest acceptable levels. | PASS |
| Biocompatibility | Based on results of toxicological review per ISO 10993-1, representative endoscopes were exposed to multiple processing cycles and extracted per ISO 10993-12. The device extracts were tested for cytotoxicity per ISO 10993-5 to verify that the device extracts were non-cytotoxic. | 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 |
| Effects of Detergent on S40 | Demonstrates that residual Revital-Ox detergent does not impact the concentration or pH of the S40 use dilution during a cycle. | PASS |
| Thermometric Testing | Thermocouples placed throughout basin, sump and processed instruments to demonstrate cycle temperature is maintained at required values. | PASS |
| Human Factors | Typical users were capable of following written instructions for use to correctly load devices into the enspire 3000 processor, attach Max Flow Connectors, insert sterilant and accessories, and successfully run the processing cycle. In addition, Service Technicians were capable of following installation and maintenance instructions for the enspire 3000 processor. | PASS |
| Electrical Safety Conformance | Meets requirements per: UL 61010-1, IEC 61010-2-040:2020, IEC 60601-1-2. | PASS |
| Software Validation | Meets requirements per: IEC 62304:2006/A1:2016. | PASS |
2. Sample Size Used for the Test Set and Data Provenance
- Simulated Use Testing (Cleaning, LCS, Duodenoscopes): Worst-case devices were processed in triplicate trials for each test.
- In Use Testing (Cleaning, Liquid Chemical Sterilization): Clinically used devices were tested, but no specific count is provided.
- Rinsing Efficacy, Biocompatibility, Material Compatibility: Representative endoscopes/devices were exposed to multiple processing cycles. No specific number for the test set is provided beyond "representative" and "multiple."
The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, beyond the "in use testing" referring to "clinically used devices," which generally implies prospective collection if part of a study, but no further detail is available.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set. The tests described are primarily functional and microbiological endpoint assessments, not requiring expert human interpretation of images or other qualitative data in the same way as, for example, a medical imaging AI study.
4. Adjudication Method for the Test Set
Not applicable. The tests involve objective measurements (e.g., chemical residual levels, microbial growth, physical changes, temperature readings, electrical safety, software requirements) rather than expert subjective assessment requiring 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
Not applicable. This is a device for cleaning and sterilizing endoscopes, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a standalone automated processing system. The tests evaluate the performance of the system itself in achieving cleaning, sterilization, and other functional criteria without human intervention affecting the core process. Human factors testing assessed user interaction, but the core efficacy tests are on the device's automated capabilities.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for the efficacy tests is based on:
- Quantitative measurements: Protein levels (< 6.4 µg/cm²), Total Organic Carbon (TOC) levels (< 12 µg/cm²).
- Microbiological testing: "No growth of organisms" for Geobacillus stearothermophilus spores.
- Chemical analysis: Verifying chemical residual levels are below acceptable levels.
- Physical evaluation: Assessing physical changes to materials.
- Temperature monitoring: Demonstrating cycle temperature is maintained at required values.
- Regulatory compliance: Conformance to electrical safety and software validation standards.
8. The Sample Size for the Training Set
The document does not describe the development or training of any AI/algorithm components, therefore, there is no information on a training set or its size. This is a physical device and chemical process, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a training set for an AI/algorithm.
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June 30, 2023
STERIS Corporation Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060
Re: K230930
Trade/Device Name: enspire 3000 Cleaning and Liquid Chemical Sterile Processing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FEB Dated: March 31, 2023 Received: April 3, 2023
Dear Anthony Piotrkowski:
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
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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 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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-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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230930
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, 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 medically 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.
| 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 3000 Series Cleaning and Liquid Chemical Sterilant Processing System K230930
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600
Contact:
Tony Piotrkowski Director, Regulatory Affairs Tel: 440-392-7437 Email: tony piotrkowski@steris.com
June 30, 2023 Summary Date:
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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Device Name 1.
| Trade Name: | enspire 3000 Cleaning and Liquid ChemicalSterilant Processing System |
|---|---|
| Device Classification: | Class II |
| Common/usual Name: | Endoscope Cleaner and Reprocessor |
| Classification Name: | Accessories, Cleaning, for Endoscope |
| Classification Number: | 21 CFR 876.1500 |
| Product Code: | FEB |
2. Predicate Device
EVOTECH Endoscope Cleaner and Reprocessor, K152189
Reference Device: SYSTEM 1 endo Liquid Chemical Sterilant Processing System, K210737
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 assess the integrity of the flexible endoscope throughout the process. The enspire 3000 processor maintains inflation of the processed device to reduce the risk of ingress of fluid during processing and the pressure monitoring is repeated at the end of the processing cycle. 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
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in drying the endoscope. The processor, which is computer controlled and continually monitored, provides documentation of each cycle.
The enspire 3000 processor utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and S40 Sterilant Concentrate for liquid chemical sterilization. S40 Sterilant 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.
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, 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), liquid chemically sterilizes the load during a controlled 6-minute exposure at 46.6 to 55°C and rinses the load with 0.2micron filtered water.
ನ. Technological Characteristic Comparison Tables
| Feature | Proposed Deviceenspire 3000 Cleaning and LiquidChemical Sterilant Processing System(CLCSPS) | Predicate DeviceEVOTECH Endoscope Cleaner andReprocessor(K152189) | Comparison |
|---|---|---|---|
| Intended UseIndicationsfor Use | The enspire™ 3000 Series Cleaning andLiquid Chemical Sterilant ProcessingSystem is intended to effectively provide apressure monitor, clean, provide liquidchemical sterilization, rinse, and air purgevalidated immersible, reusable, semi-critical, heat sensitive medical devices suchas flexible endoscopes and their accessories. | The EVOTECH® ECR EndoscopeCleaner and Reprocessor, awasher/disinfector, is indicated for usewith high-leveldisinfectant CIDEX® OPA ConcentrateSolution and an enzymatic detergent(CIDEZYME XTRA) to achievecleaningand high level disinfection of heatsensitive $(>60°C)$ semi-critical | Similar. Theenspire 3000Processor monitorsthe pressure of thedevices and cleansdevices like theEVOTECH ECR.The enspire 3000Processor providesliquid chemical |
| Feature | Proposed Deviceenspire 3000 Cleaning and LiquidChemical Sterilant Processing System(CLCSPS) | Predicate DeviceEVOTECH Endoscope Cleaner andReprocessor(K152189) | Comparison |
| The validated cleaning process replacescleaning for endoscopes other thanduodenoscopes. Manual cleaning ofduodenoscopes according to themanufacturer's written instructions for useis required prior to placement in theenspire™ 3000 Series Processor.The enspire™ 3000 Series Processor usesonly Revital-Ox 2X Concentrate Enzymaticdetergent to clean and S40 SterilantConcentrate to liquid chemically sterilizemedical devices. It automatically dilutes theS40 Sterilant Concentrateto its use dilution (> 1820 mg/L peraceticacid), liquid chemically sterilizes the loadduring a controlled 6-minute exposure at46.6 to 55°C and rinses the load with 0.2-micron filtered water. | endoscopes. Manual cleaning ofmedical devices(endoscopes) is not required prior toplacement in the EVOTECH® ECREndoscope Cleaner and ReprocessorSystemwhen selecting those cycles that containa wash stage. (Manual cleaning ofmedical devices (endoscopes) isrequired whenselecting the Disinfect only orDisinfect/Alcohol Flush Cycle.) | sterilization whilethe EVOTECHECR provides highlevel disinfection. | |
| OperatingPrinciples /Technology | Microprocessor controlled unit with a fixed basin. The processor lid is opened with hands-free lid operation. Devices with internal lumens areinterfaced with the processor usingconnectors, i.e. Max Flow Units Instrument pressure monitoringperformed at beginning and end ofcycle to monitor endoscope pressure Revital-Ox 2X Concentrate EnzymaticDetergent is dispensed for the cleaningphase of the processing cycle. Single-use cup of S40 SterilantConcentrate is placed in a specializedcompartment; when the processor fillswith water during the LCS phase of theprocessing cycle, it creates the sterilantuse dilution The processor automatically rinses theload with 0.2 micron filtered water aftercleaning and LCS phases HEPA-filtered air purge to aid indrying | Microprocessor controlled unit withtwo basins. The processor lid is opened with afoot pedal. Devices with internal lumens areinterfaced with the processor usingconnectors, i.e. EVOTECHConnector Instrument leak test performed atbeginning and end of cycle tomonitor endoscope integrity Automatic blockage detectionsystem CIDEZYME XTRA MultiEnzymatic Detergent dispensedduring wash phase of theprocessing cycle. CIDEX OPA Concentrate HighLevel Disinfectant dispensed duringHLD phase of the processing cycle. Processor provides rinsing with 0.2micron filtered water after cleaningand disinfection phases Optional alcohol rinse at end ofcycle to aid in drying. | Similar |
| ProcessParameters | Standardized cycle parameters cannot bealtered by the operator. The critical processparameters monitored during processing: | Critical process parameters monitoredduring processing:Cleaning time | Similar |
| Feature | Proposed Deviceenspire 3000 Cleaning and LiquidChemical Sterilant Processing System(CLCSPS) | Predicate DeviceEVOTECH Endoscope Cleaner andReprocessor(K152189) | Comparison |
| Detergent dilution and cleaning time Detergent dilution temperature Use dilution contact time Use dilution temperature | HLD contact time and temperature MEC Monitor of CIDEX OPA concentration | ||
| ProcessMonitors | The processor monitors and controls the detergent and LCS use dilution phase times. Cycle record documents successful cycle completion or identifies fault if cycle aborts Alarms if RTDs indicate temperature out of specification Alarms if pressure switch indicates that high pressure pump is not operating Alarms if pressure transducer indicates circulation pressure is out of specification Alarms if internal water filter failed Filter Pressure Monitor Test. Alarms if loss of pressure inside of endoscope indicates a leak | The processor monitors and controls the detergent and HLD contact times. Cycle record documents successful cycle completion or identifies fault if cycle aborts Alarms if loss of pressure inside of endoscope indicates a leak Monitors HLD contact time and temperature MEC Monitor will abort cycle if CIDEX OPA Concentrate solution does not meet preset limits | Similar |
| DesignFeatures | Unalterable and standardized Processing Cycle for cleaning and liquid chemical sterilization Filter Pressure Monitor Test for demonstrating 0.2 micron water filter maintains functionality after replacement or power outage Automated stand-alone system with one reprocessing basin Basin lid features a rotating spray arm. Intended for use with only Revital-Ox 2X Concentrate Enzymatic Detergent and S40 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 | Multiple processing cycles available by turning on or off the Wash and Alcohol Flush features: Wash, Disinfect, and Alcohol Flush Wash and Disinfect Cycle Disinfect and Alcohol Flush Disinfect Only Cycle Self-Disinfection Cycle Automated stand-alone system with two operating reprocessing basins comprising hardware, software and consumables. Basin lid features a rotating spray arm. Designed to perform process using only CIDEZYME XTRA Multi Enzymatic Detergent and high level disinfection using only CIDEX OPA. Processor provides rinsing with 0.2 micron filtered water after wash and disinfect phases Includes Bar code scanner, employs touchscreen display interface; has | Similar. enspire 3000 Processor has one unalterable processing cycle that always includes cleaning and liquid chemical sterilization. |
| Feature | Proposed Deviceenspire 3000 Cleaning and LiquidChemical Sterilant Processing System(CLCSPS) | Predicate DeviceEVOTECH Endoscope Cleaner andReprocessor(K152189) | Comparison |
| 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 | USB drive for electronic cycle download Printer integral to unit. | ||
| Cycle Parameters | Comparison | ||
| PressureMonitor Test | Performed at beginning and end of cycle | Performed at beginning and end of cycle | Same |
| Pre-RinsePhase | Pre-filtered water at 40°C | 0.2 micron filtered water at 35°C | Similar |
| IncomingWater Temp | 37 - 45°C | 37°C | Similar |
| CleaningPhaseTemperature | > 42.2°C | 37°C | Similar |
| CleaningPhaseExposureTime | 2 minutes | Not identified | No informationprovided for thepredicate |
| Rinse PhaseafterCleaning | Pre-filtered water below 55°C | 0.2 micron filtered water at 45°C | Similar |
| HLD or LCSPhaseTemperatureRange | LCS: 46.6 - 50°C | HLD: Minimum of 50°C | Similar |
| HLD or LCSPhaseExposureTime | 6 minutes | Minimum of 5 minutes | Similar |
| Rinse Phaseafter HLD orLCS | Hot potable tap water that is pre-filteredthen filtered through a 0.2 micron bacterialretentive filter | 0.2 micron filtered water at 30°C forfirst rinse, then at 25°C for second rinse | Similar |
| Number ofrinses | 2 after Cleaning Phase2 after LCS Phase | 1 after Wash Phase2 after Disinfection Phase | Similar |
| AlcoholRinse | No | Yes, if selected in cycle | enspire 3000processor does notoffer alcohol flush |
| Air Purge | Yes | Yes | Same |
| ApproximateCycle Time | 38 minutes | 33 minutes | Similar |
| Accessories | Comparison | ||
| Detergent | Revital-Ox 2X Concentrate EnzymaticDetergent | CIDEZYME XTRA Multi EnzymaticDetergent | Both are enzymaticdetergents |
| High LevelDisinfectant | N/A | CIDEX OPA | enspire does notprovide HLD. |
| Feature | Proposed Deviceenspire 3000 Cleaning and LiquidChemical Sterilant Processing System(CLCSPS) | Predicate DeviceEVOTECH Endoscope Cleaner andReprocessor(K152189) | Comparison |
| LiquidChemicalSterilant | S40 Sterilant Concentrate | N/A | EVOTECH ECRdoes not liquidchemically sterilizedevices. |
| Connectors | Max Flow Connectors | EVOTECH Connectors | Similar, bothprovide a means toattach instrumentsfor flow of internallumens duringprocessing |
| ChemicalIndicator | Celerity Chemical Indicator for enspire3000 Cleaning and Liquid Chemical SterileProcessing System | Integrated automated MinimumEffective Concentration (MEC) testingduring cycle | Both providemeans ofconfirminggermicide reachedeffectiveconcentration |
| Spore TestStrip | VERIFY Spore Test Strip for S40 Sterilant | N/A | Spore Test Strip isnot recommendedor cleared for usewith the predicatedevice. |
| OperatorMaintenance | Periodic replacement of detergent, waterfilters and air filter. Periodic replacementof printer tape if using the external printeroption. Cleaning outside of the unit andbasin drain screen as needed. | Cleaning seals, replacing solutions,replacing 0.2 micron filters, cleaningcoarse screen, cleaning drip tray, printerpaper replacement, cleaning fan filter | Similar |
Table 1. Predicate Device Comparison Table
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Table 2. Reference Device Comparison Table
| Feature | Proposed Deviceenspire 3000 Cleaning and LiquidChemical Sterilant Processing System(LCSPS) | Reference DeviceSYSTEM 1 endo Liquid ChemicalSterilant Processing System, ModelP6900(K210737) | Comparison |
|---|---|---|---|
| Intended UseIndicationsfor Use | The enspire™ 3000 Series Cleaning andLiquid Chemical Sterilant ProcessingSystem is intended to effectively providea pressure monitor, clean, provide liquidchemical sterilization, rinse, and air purgevalidated immersible, reusable, semi-critical, heat sensitive medical devicessuch as flexible endoscopes and theiraccessories. | The SYSTEM 1 endo Liquid ChemicalSterilant Processing System is intendedfor liquid chemical sterilization ofcleaned, immersible, and reusablesemi-critical, heat-sensitive medicaldevices and their accessories inhealthcare facilities. | Similar. The enspireProcessor monitors thepressure of the deviceand cleans devices inaddition to liquidchemical sterilization. |
| The validated cleaning process replacescleaning for endoscopes other thanduodenoscopes. Manual cleaning ofduodenoscopes according to the | The SYSTEM 1 endo Processautomatically dilutes the S40 SterilantConcentrate to its use dilution (> 1820mg/L peracetic acid), liquid chemicallysterilizes the load during a controlled6-minute exposure at 45.5 to 60°C and | enspire 3000 CLCSPSreplaces manualcleaning of medicaldevices exceptingduodenoscopes | |
| Feature | Proposed Deviceenspire 3000 Cleaning and LiquidChemical Sterilant Processing System(LCSPS) | Reference DeviceSYSTEM 1 endo Liquid ChemicalSterilant Processing System, ModelP6900(K210737) | Comparison |
| manufacturer's written instructions foruse is required prior to placement in theenspire™ 3000 Series Processor.The enspire™ 3000 Series Processor usesonly Revital-Ox 2X ConcentrateEnzymatic detergent to clean and S40Sterilant Concentrate to liquid chemicallysterilize medical devices. It automaticallydilutes the S40 Sterilant Concentrateto its use dilution (> 1820 mg/L peraceticacid), liquid chemically sterilizes theload during a controlled 6-minuteexposure at 46.6 to 55°C and rinses theload with 0.2-micron filtered water. | rinses the load with 0.2 micron filteredwater.The SYSTEM 1 endo Process usesonly S40 Sterilant Concentrate toliquid chemically sterilize medicaldevices. | ||
| OperatingPrinciples /Technology | 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 monitor performed at beginning and end of cycle to monitor endoscope pressure 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 | A microprocessor controlled unit with interchangeable processing trays/containers. The processor lid opens to reveal the processing chamber in which the load is placed. Devices with internal lumens are interfaced with the processor using connectors, i.e. Quick Connects. S40 Sterilant is placed in a specialized compartment and when the processor fills with water, it creates the sterilant use dilution from the single use sterilant cup. The processor monitors and controls the use dilution contact time. The processor automatically rinses the load with 0.2 micron filtered water to remove sterilant residuals. | Similar. enspire 3000Processor hasadditional pressuremonitor and cleaningcapabilities. |
| ProcessParameters | Standardized cycle parameters cannot bealtered by the operator. The criticalprocess parameters monitored duringprocessing:Detergent dilution and cleaning time Detergent dilution temperature | Standardized cycle parameters cannotbe altered by the operator. The criticalprocess parameters are:Use dilution contact time Use dilution temperature Peracetic acid concentration | Similar |
| Feature | Proposed Deviceenspire 3000 Cleaning and LiquidChemical Sterilant Processing System(LCSPS) | Reference DeviceSYSTEM 1 endo Liquid ChemicalSterilant Processing System, ModelP6900(K210737) | Comparison |
| Use dilution contact time Use dilution temperature | Integrity of the internal water filter (tested by the system) | ||
| ProcessMonitors | The processor monitors and controls the detergent and LCS use dilution phase times. Cycle record documents successful cycle completion or identifies fault if cycle aborts Alarms if RTDs indicate temperature out of specification Alarms if pressure switch indicates that high pressure pump is not operating Alarms if pressure transducer indicates circulation pressure is out of specification Alarms if internal water filter failed Filter Integrity Test. Alarms if loss of pressure inside of endoscope indicates a leak | Cycle record documents successful cycle completion or identifies fault if cycle aborts Alarms if thermocouples indicate temperature out of specification Alarms if pressure switch indicates that high pressure pump is not operating Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification in Diagnostic Cycle Alarms if pressure transducer indicates internal water filter failed integrity test. | Similar |
| DesignFeatures | Unalterable and standardized Processing Cycle for cleaning and liquid chemical sterilization Filter Integrity Test for demonstrating 0.2 micron water filter maintains functionality after replacement or power outage Automated stand-alone system with one reprocessing basin Basin lid features a rotating spray arm. Intended for use with only Revital-Ox 2X Concentrate Enzymatic Detergent and S40 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 | Microprocessor controlled unalterable and standardized Liquid Chemical Sterilization and Diagnostic Cycles Intended for use with only S40 Sterilant Concentrate Automated dilution and delivery of S40 Sterilant Processor provides 0.2 micron filtered water for liquid chemical sterilization and rinsing Make-up air for processor during drain 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 | Similar. enspire 3000Processor hasadditional cleaningcapabilities. |
| Feature | Proposed Deviceenspire 3000 Cleaning and LiquidChemical Sterilant Processing System(LCSPS) | Reference DeviceSYSTEM 1 endo Liquid ChemicalSterilant Processing System, ModelP6900(K210737) | Comparison |
| Compressed air for processor duringdrain sequence is filtered through a0.2 micron membrane air filterIncludes a bar code scanner; employstouchscreen display interface; hasUSB drive for electronic cycledownload; facilitates use of a web-based data management system.Separate, optional printer | |||
| Cycle Parameters | Comparison | ||
| PressureMonitor Test | Performed at beginning and end of cycle | N/A | Pressure monitor notavailable on SYSTEM1 endo |
| Pre-RinsePhase | Pre-filtered water at 40°C | N/A | Cleaning not availableon SYSTEM 1 endo |
| IncomingWater Temp | 37 - 45°C | $\ge$ 43°C | Cleaning not availableon SYSTEM 1 endo |
| CleaningPhaseTemperature | > 42.2°C | N/A | Cleaning not availableon SYSTEM 1 endo |
| CleaningPhaseExposureTime | 2 minutes | N/A | Cleaning not availableon SYSTEM 1 endo |
| Rinse Phaseafter Cleaning | Pre-filtered water below 55°C | N/A | Cleaning not availableon SYSTEM 1 endo |
| LCS PhaseTemperatureRange | LCS: 46.6 - 50°C | 46 - 55°C | Identical |
| LCS PhaseExposureTime | 6 minutes | 6 minutes | Identical |
| Rinse Phaseafter LCSPhase | Hot potable tap water that is pre-filteredthen filtered through a 0.2 micronbacterial retentive filter | Hot potable tap water that is pre-filtered then filtered through a 0.2micron bacterial retentive filter | Identical |
| Number ofrinses | 2 after Cleaning Phase2 after LCS Phase | 2 after LCS Phase | Additional rinses onenspire 3000 CLCSPSdue to cleaning phase |
| Air Purge | Yes | Yes | Identical |
| ApproximateCycle Time | 38 minutes | 18-20 minutes | enspire has additionaltime for cleaning phase |
| Accessories | Comparison | ||
| Detergent | Revital-Ox 2X Concentrate EnzymaticDetergent | N/A | Cleaning not availableon SYSTEM 1 endo |
| Feature | Proposed Deviceenspire 3000 Cleaning and LiquidChemical Sterilant Processing System(LCSPS) | Reference DeviceSYSTEM 1 endo Liquid ChemicalSterilant Processing System, ModelP6900(K210737) | Comparison |
| LiquidChemicalSterilant | S40 Sterilant Concentrate | S40 Sterilant Concentrate | Identical |
| Connectors | Max Flow Connectors | Quick Connects | Similar, both provide ameans to attachinstruments for flow ofinternal lumens duringprocessing |
| ChemicalIndicator | Celerity Chemical Indicator for enspire3000 Cleaning and Liquid ChemicalSterile Processing System | VERIFY Chemical Indicator for S40Sterilant is available for use inSYSTEM 1 endo LCSPS | Both provide means ofconfirming sterilantreached effectiveconcentration |
| Spore TestStrip | VERIFY Spore Test Strip for S40Sterilant | VERIFY Spore Test Strip for S40Sterilant for use in SYSTEM 1 endoLCSPS | Identical |
| OperatorMaintenance | Periodic replacement of detergent, waterfilters and air filter. Periodic replacementof printer tape if using the external printeroption. Cleaning outside of the unit andbasin drain screen as needed. | Periodic replacement of water filtersand air filter. Periodic replacement ofprinter tape if using the external printeroption. | Similar. Detergent notused in SYSTEM 1endo |
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Table 3. S40 Sterilant Concentrate Device Comparison Table
| Feature | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| S40 Sterilant Concentrate | S40 Sterilant Concentrate (K211607) | ||
| Indications for Use | The SYSTEM 1E Processor uses onlyS40 Sterilant Concentrate to liquidchemically sterilize medical devices. | The SYSTEM 1E Processor uses onlyS40 Sterilant Concentrate to liquidchemically sterilize medical devices. | Identical |
| Germicidal claim | Liquid Chemical Sterilant | Liquid Chemical Sterilant | Identical |
| GermicideExposure Time | 6 minutes | 6 minutes | Identical |
| Use Temperature | 45.5-60°C – allowable46-55°C - typicalPotency and simulated use evaluationsconducted at ≤43°C | 45.5-60°C – allowable46-55°C - typicalPotency and simulated use evaluationsconducted at ≤43°C | Identical |
| Reuse | Single use | Single use | Identical |
| Human Factors | Dispensed ready to use. Container isopened and diluted by the processor, thuslimiting user exposure to the activeingredient | Dispensed ready to useContainer is opened and diluted by theprocessor, thus limiting user exposure tothe active ingredient | Identical |
| Active Ingredient | 35% peroxyacetic (peracetic) acidautomatically diluted for use in theSYSTEM 1E Processor. | 35% peroxyacetic (peracetic) acidautomatically diluted for use in theSYSTEM 1E Processor. | Identical |
| Mode of Action | It is believed that peracetic acid exerts itsgermicidal effect by several mechanisms: | It is believed that peracetic acid exerts itsgermicidal effect by several mechanisms: | Identical |
| Feature | Proposed DeviceS40 Sterilant Concentrate | Predicate DeviceS40 Sterilant Concentrate (K211607) | Comparison |
| -oxidizing sulfhydryl and sulfur bonds inproteins and enzymes, particularly in thecell walls-hydroxyl radicals produced from PAAare bactericidal-PAA damages the viral capsid and viralnucleic acid. | -oxidizing sulfhydryl and sulfur bonds inproteins and enzymes, particularly in thecell walls-hydroxyl radicals produced from PAAare bactericidal-PAA damages the viral capsid and viralnucleic acid | ||
| Rinses | Automatic, UV-irradiated, dual 0.1micron filtered, potable hot water. | Automatic, UV-irradiated, dual 0.1micron filtered, potable hot water. | Identical |
| Microbial Efficacy | |||
| SporicidalActivity ofDisinfectantsAOAC OfficialMethod 966.04 | Meets efficacy requirements.Bacillus subtilisClostridium sporogenesTesting conducted in vitro | Meets efficacy requirements.Bacillus subtilisClostridium sporogenesTesting conducted in vitro | Identical |
| ConfirmatorySporicidalActivity ofDisinfectantsAOAC OfficialMethod 966.04 | Meets efficacy requirements.Bacillus subtilisClostridium sporogenesTesting conducted in vitro | Meets efficacy requirements.Bacillus subtilisClostridium sporogenesTesting conducted in vitro | Identical |
| FungicidalActivity ofDisinfectantsAOAC OfficialMethod 955.17 | Solution is fungicidal.Trichophyton mentagrophytesTesting conducted in vitro | Solution is fungicidal.Trichophyton mentagrophytesTesting conducted in vitro | Identical |
| Use DilutionMethod AOAC,Official Methods955.14, 955.15,964.02 | Solution is bactericidal.Salmonella choleraesuisStaphylococcus aureusPseudomonas aeruginosaTesting conducted in vitro | Solution is bactericidal.Salmonella choleraesuisStaphylococcus aureusPseudomonas aeruginosaTesting conducted in vitro | Identical |
| EPA ViricidalTesting(DIS/TSS-7, Nov.1981) | Solution is viricidal.Herpes simplex Type 1Adenovirus Type 5Poliovirus Type 1Testing conducted in vitro | Solution is viricidal.Herpes simplex Type 1Adenovirus Type 5Poliovirus Type 1Testing conducted in vitro | Identical |
| TuberculocidalActivity AscenziQuantitativeSuspension Test | Solution is tuberculocidalMycobacterium terraeTesting conducted in vitro | Solution is tuberculocidalMycobacterium terraeTesting conducted in vitro | Identical |
| Simulated-UseTest | Meets efficacy requirement.> 6 log reduction Geobacillusstearothermophilus spores in a manualapplication | Meets efficacy requirement.> 6 log reduction Geobacillusstearothermophilus spores in a manualapplication | Identical |
| Clinical In-Use | No surviving microorganisms onrepresentative medical devices tested | No surviving microorganisms onrepresentative medical devices tested | Identical |
| Biocompatibility | |||
| Feature | Proposed DeviceS40 Sterilant Concentrate | Predicate DeviceS40 Sterilant Concentrate (K211607) | Comparison |
| CytotoxicityDevice Extracts | Two rinses with UV treated dual 0.1-micron membrane filtered watereffectively reduce sterilant residues tosafe levels. | Two rinses with UV treated dual 0.1-micron membrane filtered watereffectively reduce sterilant residues tosafe levels. | Identical |
| Residue Reduction | Automatic within the SYSTEM 1EProcessor:Two rinses with UV treated dual 0.1-micron membrane filtered watereffectively reduce sterilant residues tosafe levels. | Automatic within the SYSTEM 1EProcessor:Two rinses with UV treated dual 0.1-micron membrane filtered watereffectively reduce sterilant residues tosafe levels. | Identical |
| Device MaterialCompatibility | Compatible with medical devices asestablished by testing finished flexibleendoscopes through 300 cycles and rigiddevices through 150 cycles.No functional changes have occurred toflexible devices.Some materials show cosmetic changessuch as fading of black anodizedaluminum without harm to the base | Compatible with medical devices asestablished by testing finished flexibleendoscopes through 300 cycles and rigiddevices through 150 cycles.No functional changes have occurred toflexible devices.Some materials show cosmetic changessuch as fading of black anodizedaluminum without harm to the base | Identical |
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Summary of Non-Clinical Testing 6.
Shown in Table 4 is the new testing that was performed to evaluate safety and effectiveness of the enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System.
material.
Table 4. Summary of verification activities.
material.
| Test | Test Description and Acceptance Criteria | Result |
|---|---|---|
| Simulated UseTesting | Cleaning: Worst-case devices were soiled and processed in triplicate using thecleaning phase of the processing cycle, then examined visually and sampled forquantitation of two soil markers: protein < 6.4 µg/cm² and TOC < 12 µg/cm². | PASS |
| Liquid Chemical Sterilization: Worst case devices were inoculated withGeobacillus stearothermophilus in triplicate trials and processed using the LCSphase of the processing cycle, then sampled to demonstrate no growth oforganisms. | PASS | |
| Liquid Chemical Sterilization of Duodenoscopes: Worst case devices wereinoculated with Geobacillus stearothermophilus in triplicate trials and processedusing an abbreviated LCS phase of the processing cycle (2.5-minute), thensampled to demonstrate no growth of organisms. | PASS | |
| In Use Testing | Cleaning: Clinically used devices were placed into the enspire 3000 processorand exposed to a full processing cycle. At the end of the cycle, the devices wereexamined visually and sampled for quantitation of two soil markers: protein < 6.4 µg/cm² and TOC < 12 µg/cm². | PASS |
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| Test | Test Description and Acceptance Criteria | Result |
|---|---|---|
| Liquid Chemical Sterilization: Clinically used devices were placed into theenspire 3000 processor and exposed to a full processing cycle. At the end of thecycle, the devices were sampled to demonstrate no growth of organisms. | PASS | |
| Rinsing Efficacy | A representative endoscope was exposed to multiple processing cycles andextracted per ISO 10993-12. The device extracts were analyzed to verifychemical residual levels were below the highest acceptable levels. | PASS |
| Biocompatibility | Based on results of toxicological review per ISO 10993-1, representativeendoscopes were exposed to multiple processing cycles and extracted per ISO10993-12. The device extracts were tested for cytotoxicity per ISO 10993-5 toverify that the device extracts were non-cytotoxic. | PASS |
| MaterialCompatibility | Representative devices were exposed to multiple processing cycles andevaluated for physical changes to demonstrate material compatibility with theprocess and chemistries used. | PASS |
| Effects ofDetergent on S40 | Demonstrates that residual Revital-Ox detergent does not impact theconcentration or pH of the S40 use dilution during a cycle | PASS |
| ThermometricTesting | Thermocouples placed throughout basin, sump and processed instruments todemonstrate cycle temperature is maintained at required values. | PASS |
| Human Factors | Typical users were capable of following written instructions for use to correctlyload devices into the enspire 3000 processor, attach Max Flow Connectors, insertsterilant and accessories, and successfully run the processing cycle. In addition,Service Technicians were capable of following installation and maintenanceinstructions for the enspire 3000 processor. | PASS |
| Electrical SafetyConformance | Meets requirements per:• UL 61010-1, Safety Requirements for Electrical Equipment forMeasurement, Control, and Laboratory Use - Part 1: GeneralRequirements, 3rd Edition• IEC 61010-2-040:2020, Safety Requirements for Electrical Equipment formeasurement, control and laboratory use - Part 2-040: ParticularRequirements for Sterilizers and Washer-Disinfectors Used to TreatMedical Materials• IEC 60601-1-2, Electrical Equipment for Measurement, Control andLaboratory Use – EMC Requirements – Part 1: General Requirements | PASS |
| SoftwareValidation | Meets requirements per:• IEC 62304:2006/A1:2016, Medical device software – Software lifecycle processes [Including Amendment 1(2016)] | PASS |
Clinical testing: Not applicable.
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 (K152189), Class II (21 CFR 876.1500), product code FEB.
§ 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.